Operational failure of clinical trials, the inability to achieve trial enrollment targets, and perform trial procedures, is a significant translational science problem. Over 50% of clinical trials fail to achieve their target enrollment. We developed a Clinical Trials Operation Risk Assessment tool to aid in prospectively estimating the risk of operational failure, identifying issues that could benefit from mitigation efforts, and to aid in investigator and institutional decisions regarding participating as a trial site.  We report interim analysis from scoring 143 clinical trials over 4 years, and were able to track 21 trials, with analysis ongoing.  We found that the CT-ORA risk score was significantly associated with a decision to participate in a trial (p=0.009), but not associated with reaching the trial accrual goal (p=0.38) at this interim analysis.


A Tool for Estimating Clinical Trial Operational Risk

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2026 Fall CTSA Program&nbsp;Annual Meeting

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The Poster Submission period for the Fall 2026 Annual Meeting is closed. For questions or support please contact us at <a href="mailto:events@ccos.ctsa.io">events@ccos.ctsa.io</a>.

The theme for this year’s poster session is “20 Years of CTSA Impact – Past, Present, and Future." The Poster Presentation Sessions offer a platform for CTSA hub-selected presenters to showcase innovative hub impact stories spanning the 20-year history of the CTSA Program.&nbsp;&nbsp;Poster Submissions open July 14 at 9:00 am ET and close August 31 at 11:59 pm ET.&nbsp;Eligible Submissions:Each hub may submit one poster related to the theme of the Poster Presentation Session, 20 Years if CTSA Impact – Past, Present, and Future, and falls within one of the four TSBM domains:<ol style="list-style-type:decimal;"><li>Clinical and medical contributions</li><li>Community and Public Health</li><li>Economic Benefits</li><li>Policy*</li></ol>&nbsp;* Hubs submitting to this category must clearly indicate that research was what the CTSA grant supported and NOT any advocacy or legislative influence activities. Per the NIH Grants Policy statement, hubs should pay special attention to reporting/describing activities focused on reporting Policy and Legislative Impacts under the TSBM model or any aspect of a NIH funded CTSA grant. However, no grant funds including personnel costs may be used for activities. Reference: &nbsp;<a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.5_lobbying_-_appropriation_prohibition.htm?Highlight=lobbying">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.5_lobbying_-_appropriation_prohibition.htm?Highlight=lobbying</a>&nbsp;&nbsp;While we recognize that posters may fit multiple TS Domains, we ask that submitters choose a primary domain for their poster submission.&nbsp;UL1/UM1 Principal Investigators are requested to work with their respective teams to select a hub initiative that exemplifies impact on Translational Science. &nbsp;&nbsp;Traditional scientific research posters are not the focus of this year’s program. This is not a juried poster session. Instead, this year’s poster session focuses on showcasing demonstrable impact in translational science and highlighting the contributions of CTSAs. &nbsp;&nbsp;Submission Instructions:<ul><li>Hub Administrators will log onto the CCOS website to submit the poster abstract and poster PDF by or before August 31 at 11:59pm ET.</li><li>Select posters will be invited to highlight key impact stories during Lightning Talks scheduled during the poster session. If you would like your hub’s poster considered for this opportunity, you will have the option to indicate interest on the poster submission form. &nbsp;</li><li>The following information will be included in your submission:<ul><li>First Author (First Name, Last Name, Credentials, Email)</li><li>Contributing Authors (First Name, Last Name, Degrees, Institution)</li><li>TSBM Domain</li><li>Poster Title (Character Limit: 1000)</li><li>Abstract (Character Limit: 3000)</li><li>PDF of Poster</li><li>Opt-in for Lightning Talk</li><li>Tags</li></ul></li><li>Upon submission, Hub Administrators and first authors will receive email confirmation of the poster submission. Changes cannot be made after submission.&nbsp;</li></ul>&nbsp;Poster Presentations:<ul><li>Poster dimensions can be a maximum of 44"H x 90"W.</li><li>Poster presenters must print their poster for onsite display.</li><li>Printing and delivery to the conference are the responsibility of the hub/presenter.</li><li>Posters will be presented on September 24, with set up occurring from 9-12pm and the session opening at 3:00pm.&nbsp;</li></ul>&nbsp;Attendance:<ul><li>Posters must be presented in-person during the Annual Program Meeting.</li><li>The limit for in-person registration is nine (9) per hub plus one (1) poster presenter, for a total of ten (10) in-person attendees (speakers are counted outside of this limit).</li></ul>&nbsp;Communications:<ul><li>Questions about the poster sessions can be directed to events@ccos.ctsa.io.</li><li>Submission confirmations will be sent automatically to the Hub Administrator and first author.</li><li>Assistance with resubmission/deletion of posters submitted in error should be directed to support@ccos.ctsa.io.</li><li>Authors will receive confirmation, additional instructions, and notifications about Lightning Talks by September 15.&nbsp;</li></ul>

Poster Submission Details

Poster Submissions are currently closed and will open July 14 at 9:00 am ET. For questions or support please contact us at <a href="mailto:events@ccos.ctsa.io">events@ccos.ctsa.io</a>.

Poster Submission

2026 Fall CTSA Program Annual Meeting, Washington, DC, Sept 23-25, 2026

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The 2026 Fall CTSA Program Annual Meeting is scheduled for September 23-25, 2026 in Washington, DC. The Steering Committee meeting will occur the day before, on September 22.

2026 Fall CTSA Program Annual Meeting

Agenda

Meeting materials will be found within the agenda once they become available.

Meeting Materials

September 22 | Steering Committee MeetingSeptember 23 | EC Plenary Session, Administrative, and Leadership MeetingsTrial Innovation Network, Hub Administrators, Enterprise Committees (BIDS, Collaboration &amp; Engagement, Integration Across the Lifespan, Workforce Development)September 24-25 | General Session Presentations, Poster Presentations, and UPI MeetingKeynote Address by Karim Mikhail, Acting Director of the FDA’s Center for Biologics Evaluation and Research (CBER). Session topics include: AI use cases in real-world research, innovative trial designs, research expansion into rural areas, workforce development and research staff career pathways and scaling recruitment services and infrastructure.

Agenda Highlights

Location:Marriott Marquis Washington DC901 Massachusetts Ave, NW,&nbsp;Washington, DC 20001&nbsp;&nbsp;Reservations:<a target="_blank" rel="noopener noreferrer" href="https://book.passkey.com/event/51291860/owner/10764415/home?utm_campaign=301000763">Marriott Reservations - 2026 Fall CTSA Program Annual Meeting</a>CCOS has reserved a limited block of rooms for this meeting. All reservations are on a first-come, first-serve basis and must be booked through the housing link. If you are experiencing unavailability of the group rate across any portion of your stay, you can contact the hotel directly for their current retail rates or search neighboring hotels for availability. Please use 901 Massachusetts Ave. NW as your starting search location. The room block closes on August 31.&nbsp;

Location and Reservations

Registration is officially open for Administrative and Leadership meetings, as well as the general sessions. Registration for the Hub Administrators and Trial Innovation Network (TIN) meetings will be managed separately, and information will be provided for those meetings.

Hub Attendance Guidelines and Registration

As of August 26, hub capacity limits for the September 24–25 general session have been removed. Registration is now open to all CTSA Consortium participants until ballroom capacity is reached.While the ballroom can accommodate additional attendees, many Enterprise Committee (EC) Meetings are held in smaller breakout rooms and have already reached capacity. As a result, we are unable to add additional participants to those sessions at this time. We encourage attendees who have registered for multiple meetings to review their itineraries and make any necessary adjustments so we can maximize participation across all EC Meetings.EC members are strongly encouraged to attend the general sessions along with your hub leadership. Their participation ensures committee perspectives are integrated into broader programmatic discussions and helps align efforts across the CTSA Program. This cross-functional engagement is vital for fostering collaboration and innovation.

Each hub may submit one poster, highlighting a project related to the theme of the Poster Session, “20 Years of CTSA Impact - Past, Present, and Future”. Posters must align with one of the Translational Science Benefits Model (TSBM) domains:<ul><li>Clinical and Medical Contributions</li><li>Community and Public Health</li><li>Economic Benefits</li><li>Policy*</li></ul>* Hubs submitting to this category must clearly indicate that research was what the CTSA grant supported and NOT any advocacy or legislative influence activities. Per the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.5_lobbying_-_appropriation_prohibition.htm?Highlight=lobbying" target="_blank" rel="noopener noreferrer">NIH Grants Policy statement</a>, hubs should pay special attention to reporting/describing activities focused on reporting Policy and Legislative Impacts under the TSBM model or any aspect of a NIH funded CTSA grant. However, no grant funds including personnel costs may be used for activities.&nbsp;UL1/UM1 Principal Investigators are requested to work with their respective teams to select a hub initiative that exemplifies impact on Translational Science.&nbsp;Traditional scientific research posters are not the focus of this year’s program. This is not a juried poster session. Instead, this year’s poster session focuses on showcasing demonstrable impact in translational science and highlighting the contributions of CTSAs.

Poster Session

&nbsp;Theme: From Discovery to Impact: Advancing the Translational Pathway

2026 Fall CTSA Program Annual Meeting

Registration (Cvent)

Since its inception as a Clinical and Translational Science Award hub in 2010, the University of California, Irvine Institute for Clinical and Translational Sciences (UC Irvine ICTS) has funded promising translational studies through Pilot Awards to nurture innovative research on the path from lab to life, and Campus-Community Collaboration Incubator (3Ci) Awards to foster deep ties for conducting impactful community-partnered science.
Each UC Irvine ICTS funding mechanism uses a rigorous selection process, with the Pilot and 3Ci awards involving community and academic reviewers to identify projects designed as the highest quality science and with a high promise of real-world impact.
From 2010-2025, the Pilot program funded 107 projects that generated 348 publications. For every dollar invested by ICTS, there was a $26.88 net return in extramural grant funding obtained for projects directly related to the pilot award. Among projects funded since 2019, 92% of Pilot projects reported one or more expected translational science benefits, with 15% of the projects resulting in a verified clinical or medical benefit within 3 years of funding.
Through the same period, the 3Ci program funded 57 campus-community partnerships that generated 114 publications. For every dollar invested by ICTS, there was a $8.90 net return in extramural grant funding obtained for projects directly related to the 3Ci award. Among projects funded since 2020, 88% of 3Ci projects reported one or more expected translational science benefits, with 17% of the projects resulting in a verified community or public health benefit within 3 years of funding.
Two standout projects from the UC Irvine ICTS awards programs, include:
Dr. Ralph Clayman’s Pilot project that developed a novel catheter with localized drug delivery for treating kidney stones, resulting in 3 demonstrated benefits in the Clinical and Medical domain. 
Dr. Mirian Ryan (community partner) and Dr. Sonia Sehgal’s 3Ci project provided support coaches for seniors and created a plain language Senior Resource Kit, resulting in four demonstrated benefits in the Community and Public Health domain and one demonstrated benefit in the Clinical and Medical domain.

15 years of Program Impact: UC Irvine CTSA Pilot Awards and Campus-Community Collaboration Incubator Awards

15 Years of Program Impact: UC Irvine CTSA Pilot Awards and Campus-Community Collaboration Incubator Awards

Introduction: The Oregon Clinical and Translational Research Institute (OCTRI) has a long-standing record of productive, meaningful engagement with Oregon communities. The well-developed Community Outreach, Research, and Engagement (CORE) infrastructure unifies the community-facing and community-serving programs of the Knight Cancer Institute Community Outreach and Engagement (COE), OCTRI, and the Oregon Rural Practice-based Research Network (ORPRN). 

Approach: OCTRI provides “backbone support” for CORE through administrative oversight and convening. 
1. Regionally Based Team Members- CORE funds Community Research Facilitators (CRFs) who live and work in communities across Oregon. CRFs maintain relationships beyond individual studies and facilitate community engagement in research. They champion community priorities; build trust between academic and community partners; support study co-design; and implement protocols.
2. Front Door- CORE Front Door is the single-entry point for academic and community partners to request support services. It strengthens OHSU’s ability to coordinate how it receives, responds to, tracks, and supports community-engaged research partnerships. 
3. CEnR Services and Projects- Services provided by CORE member organizations support community engagement and community-engaged research and may include partnership connections, project planning and co-design, grant and contract development, project implementation, evaluation, and dissemination. Services and support cover all stages of the research process and span all CORE member programs’ offerings. 

Impact: CORE uses the Translational Science Benefit Model (TSBM) to assess the real-world impacts of our translational research. 
1. Regionally Based Team Members- Community and public health. CORE leverages cross-program resources to develop and maintain meaningful academic-community connections. We empower communities as research partners and decision-makers. We provide relevant tools and resources to our clinic, community, and patient partners.
2. CORE Front Door- Community & public health. CORE engages community partners at all stages of the research process, generating buy-in for participation and for using research findings to inform organization-level actions. 
3. CEnR Services and Projects- Community and public health. Clinical and medical. CORE offers and implements a portfolio of services for academic and community partners that engage patients and communities throughout all stages of the research process. We conduct research that supports implementing evidence-based practices in community settings, centered on person-centered care.

Looking Ahead: CORE will continue to build on our strengths in community engagement and community-engaged research to overcome roadblocks in translational science, accelerate clinical and translational research, and deliver Community and Clinical benefits to all – especially people residing in rural settings.

20 Years and Beyond: How OCTRI has advanced -and will continue to advance- community and clinical benefits through cross-program collaboration

Title: A Decade of Innovation. A Lifetime of Impact. 10 Years of the Trial Innovation Network
Background: The Trial Innovation Network (TIN), a partnership funded by the National Center for Advancing Translational Sciences (NCATS) within the Clinical and Translational Science Award (CTSA) program, addresses critical challenges in multi-site clinical research. By leveraging the extensive national CTSA infrastructure, its network partners, and fostering collaboration, the TIN accelerates the translation of innovative research into therapeutic solutions. This poster shows the work the TIN has done for the past 10 years.
Methods: Two Trial Innovation Centers (Johns Hopkins University, Vanderbilt University Medical Center) and one Recruitment Innovation Center (Vanderbilt University Medical Center) provide no cost consultation services for multicenter studies, connecting clinical investigators with domain experts, strategic partners, and leveraging the entire CTSA network to optimize trial design and operational efficiency. The TICs and RIC have formed partnerships with more than a dozen CTSAs to enhance and strengthen the TIN consultation experience. 
Results: By working closely with investigators, the TICs and RIC have provided resources and facilitated numerous successful consultations across the TIN. They have been able to embed and test their innovations into the clinical trials that come through the TIN proposal and consultation process
Conclusion: The TIN offers a sustainable model for overcoming barriers in multisite clinical trials with innovative solutions, supporting the future optimization of clinical research.


A Decade of Innovation. A Lifetime of Impact. 10 Years of the Trial Innovation Network 

Emerging CTSA impact work increasingly applies the Translational Science Benefit Model (TSBM) at scale, demonstrating how outputs can be systematically classified into translational benefit categories that extend beyond traditional publication counts (Luke et al.,2018). A Translational Economic Evaluation Matrix (TEEM) framework is presented, described, and applied to a real case (CTSA research pilot funding) which is informed by available economic evaluation literature, builds on the TSBM domains and indicators, extends the iterative evaluation logic, incorporates investigator-facing prospective impact planning, and addresses the need for time-specific and economic benefit assessment recommendations. 

The eight specific economic benefits proposed by the TSBM are reviewed, as well as the iterative nature of the stages of translation. The TEEM framework, which incorporates the use of the eight TSBM economic categories, the stages of translation (T0-T4), as well as temporal evaluation orientations involving prospective, cross- sectional, and retrospective designs, is presented. Five operational steps to applying the framework are reviewed: 1) defining the evaluation purpose; 2) establishing the evaluation’s (temporal) orientation(s) to support; 3) locating the evaluation translationally; 4) selecting and applying appropriate economic method(s) (e.g., cost utility, return on investment, regional economic impact analysis, etc.); and 5) characterizing evidentiary significance and TSBM domain linkage.

A prospectively oriented case is presented using a funded research pilot investigating euglycemic diabetic ketoacidosis (euDKA) and the cost associated with hospitalization and morbidity. The case displays the potential impact of utilizing positive findings from the pilot study involving the TSBM categories of research study cost effectiveness and reduced cost of illness and mortality. It is suggested that the proposed TEEM framework can be useful to CTSA evaluators and administrators in evaluating translational assets for which scientific, operational, economic, and societal value mature over time.


A Proposed Translational Economic Evaluation Matrix (TEEM) Framework for CTSA Impact

Starting in the late 1990s, a growing number of newborns are exposed to addictive drugs before birth--usually a prescription pain killer, heroin, or fentanyl--and begin withdrawal after delivery. Newborns with this condition, neonatal abstinence syndrome (NAS), have a range of signs of withdrawal and can stay in the hospital for weeks. As of 2021, more than one newborn developed NAS every 25 minutes (1).
Until 2017, there was no research on which medicines best treat NAS. Clinicians were using drugs created for adults and estimating the doses for neonates.  
In 2012, Dr. Jon Davis and a team at Tufts Medical Center led the first large study with newborns to compare the most used drug treatment (morphine) to a longer-acting medicine (methadone). They faced many obstacles--legal barriers to studies with controlled substances; difficulty recruiting mothers due to stigma, legal fears, drug side effects, and narrow inclusion criteria; and social and regulatory concerns about research risks to babies. 
Tufts Clinical and Translational Science Institute (CTSI) helped make this study possible. Biostatisticians carefully designed and redesigned the protocol to receive NIH funding for a multi-site study and expertly analyzed complex data. Tufts CTSI also provided a Data & Safety Monitoring Board and assisted Dr. Davis in engaging regulators to address research obstacles.
Study results were surprising. The longer-acting medicine (methadone), not the standard of care (morphine), led to fewer days of treatment and shorter hospital stays. Around the same time, another study corroborated these findings with a similar longer-acting medicine (buprenorphine).
Based on these results, the American Academy of Pediatrics published new guidelines recommending that the longer-acting medicines be used to shorten treatment length and hospital stays, which can lower health care costs. Protocols for compounding a safer drug formulation and symptom-based dosing also became available.
Just as important, the research helped improve the environment for studying treatments for newborns. Dr. Davis worked with regulators and legislators to ensure treatments for newborns are shown to be safe and effective, including the Protecting our Infants Act of 2015 and requiring that the Food and Drug Administration (FDA) have experts in newborn medicine (2). He joined FDA committees and worked with national and international partners to develop best practices for neonatal research.
This study influenced NAS treatment--reducing patient suffering, family burden, and hospital costs--and strengthened the climate for research with newborns. What began as a question about treating newborns with NAS at one hospital grew into a national effort to improve care for some of the smallest and most vulnerable patients.
1Thomas SA, et al., Neonatal Abstinence Syndrome in the MATernaL and Infant clinical NetworK, Hosp Pediatr, 2025.
2The CTSI grant funded only the research activities in this impact story.

A Study to Help Newborns Suffering from Opioid Withdrawal Informed Changes in Neonatal Research 

Established in 2012, the University of Miami Clinical and Translational Science Institute (Miami CTSI) has developed, demonstrated, and disseminated programs that accelerate research across the translational science spectrum – from basic, pre-clinical, and clinical research to clinical implementation and public health outcomes. Miami CTSI’s strategies are shaped by the needs of various stakeholders, including research teams, patients, community members, community organizations, and health experts. The Miami CTSI creates significant translational impact, and in particular community and public health benefits, through initiatives such as funding pilot projects, establishing infrastructure to support research, and creating community engagement resources and opportunities. As highlighted in the poster, examples of these include: Funding Pilot Projects: A 2024 Clinical and Translational Science (CTS) pilot project established a scientific foundation for using large language models in improving public attitudes and intentions to participate in clinical trials, directly addressing the persistent translational science barrier of low participant enrollment in clinical trials. Infrastructure to Support Research: SCAN360, a research-enabling platform, visualizes local disease burden in Florida and has enabled research and health intervention strategies in communities in South Florida for diseases such as cervical cancer. Community Engagement Resources & Opportunities: CTSI-developed programs focusing on community engagement enable meaningful connections between community organizations and researchers and build strong academic-community partnerships based on mutual trust. Together, these CTSI initiatives demonstrate benefits in community collaboration and partnerships, community health services, healthcare delivery, healthcare accessibility, health education resources and disease prevention and reduction.

Advancing Miami CTSI Initiatives Towards Community and Public Health Benefits

Successful translation of scientific discoveries into medical products requires regulatory expertise, infrastructure, and workforce development. Recognizing the challenges academic investigators face in navigating FDA requirements, Duke University leveraged support from the Clinical and Translational Science Award (CTSA) Program to establish regulatory affairs resources that accelerate translational research.
What began as a CTSA-supported service evolved into a comprehensive regulatory ecosystem that now serves as a cornerstone of Duke's translational research enterprise. Duke institutionalized these efforts through creation of the Office of Regulatory Affairs & Quality (ORAQ) in 2016 and further integrated regulatory support into its research infrastructure by requiring ORAQ engagement for Duke-sponsored FDA-regulated submissions in 2022. This progression illustrates how CTSA-supported innovation can create sustainable institutional capacity.
ORAQ provides regulatory strategy, FDA submission support, workforce development, and technology-enabled solutions that advance translational research from discovery through clinical investigation. Since its inception, ORAQ has supported more than 4,700 FDA submissions, averaging over 250 annually. To improve efficiency, oversight, and compliance, ORAQ developed a centralized regulatory project database that has supported more than 675 projects and facilitated management of over 2,000 FDA submissions. The database has also been shared with 12 CTSA institutions, extending its impact across the consortium.
To strengthen the regulatory workforce, ORAQ established the Regulatory Affairs Training Program (RATP), which has trained more than 16,000 participants worldwide. ORAQ also developed Sponsor and Investigator Training Modules, which have trained 172 Duke faculty and 497 staff and have been distributed to more than 40 institutions. These programs expand regulatory knowledge and promote best practices across the clinical research workforce.
ORAQ's impact extends nationally through the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) and Transforming Expanded Access to Maximize Support and Study (TEAMSS) initiatives. ReGARDD provides investigators with freely accessible regulatory resources, templates, and tools for FDA-regulated research, while TEAMSS develops best practices and educational resources to improve expanded access programs and patient access to investigational therapies. Together, these initiatives strengthen institutional capacity, expand regulatory expertise, and support more efficient translation of medical innovations into patient care.
As the CTSA Program marks 20 years of impact, ORAQ demonstrates how strategic investment in regulatory affairs can evolve from a grant-supported resource into a sustainable institutional asset that advances translational research, develops the workforce, enables clinical innovation, and amplifies impact far beyond a single institution.

Advancing Translational Science Through Regulatory Infrastructure, Workforce Development, and National Collaboration: Twenty Years of CTSA Impact at Duke University

Background: Clinical translation needs scientific discoveries with effective infrastructure, innovative technologies, and multidisciplinary collaborations that enable discoveries to progress toward improved patient care. The Translational Science Benefits Model (TSBM) provides a structured framework for evaluating these downstream impacts. We apply the Clinical & Medical domain of the TSBM to evaluate how Clinical and Translational Science Award (CTSA) investments catalyzed the development of the Center for Regenerative Medicine of Boston University & Boston Medical Center (CReM) and advanced regenerative medicine along the translational continuum.

Methods: An adapted translational science case study was conducted using institutional records, program documentation, publicly available reports and data, and historical milestones describing CReM's development. The evaluation mapped major CTSA-supported investments over time to the Clinical & Medical domain of the TSBM through the developmental pathway of CReM from its initial 2009 Boston University CTSI Pilot Award through the establishment of an Affinity Research Collaborative, institutional support as a university center, the CTSA-supported TL1 Training Program, and its subsequent growth as an internationally recognized regenerative medicine center.  

To evaluate translational impact, identified milestones and outputs are systematically mapped to the Clinical & Medical domain of the TSBM, examining how CTSA-supported investments contributed to the development of disease models, regenerative medicine technologies, investigative procedures, and biological factors that advance clinical research and enable future improvements in patient care.

Results: CTSA investments supported the evolution of CReM from a pilot into an internationally recognized regenerative medicine center. Within the Clinical & Medical domain, these investments enabled the development and dissemination of induced pluripotent stem cell technologies, human disease models, organoid systems, gene editing approaches, and shared resources that improve investigators' ability to study disease mechanisms and evaluate therapeutic strategies. CTSA-supported infrastructure also fostered sustained collaboration among basic scientists, engineers, and clinician-investigators, accelerating translational research across multiple disease areas. The establishment of the TL1 Program further strengthened the clinical translational workforce by preparing investigators to move regenerative discoveries toward clinical application using interdisciplinary translational science competencies.

Conclusions: Rather than evaluating a single scientific breakthrough, this poster illustrates how sustained investments in research infrastructure, collaboration, and workforce development create the conditions necessary for future innovation. The CReM demonstrates how CTSA-supported ecosystems accelerate progress from discovery to improved clinical care.


Applying the Translational Science Benefits Model (TSBM) to Evaluate 17 Years of CTSA Investment: A Case Study of the Center for Regenerative Medicine of Boston University & Boston Medical Center (CReM)

Kentucky, including Central Appalachia, experiences some of the nation's highest rates of heart disease, cancer, and drug overdose, among other significant health disparities. In response to these challenges, the University of Kentucky's Center for Clinical and Translational Science (UK CCTS) was established in 2006. Through research funding, training, infrastructure, and community engagement, the UK CCTS fosters innovative team science to address these and other critical health issues among Kentuckians. A key component of the UK CCTS mission is also to support programming that prepares the next generation of clinical and translational researchers.

One such initiative is the KL2 Career Development Program, which provides funding to early-career scientists while supporting them in developing clinical and translational research via structured coursework, experiential learning, mentored research, team science, and leadership training. The first scholars were awarded funding through the KL2 Career Development Program in 2011. Since then, 26 faculty members have completed the program – 97% of whom graduated from the program having submitted a grant application as Principal Investigator.

Using the Translational Science Benefits Model, this project features case studies of three UK CCTS KL2 Scholars – two graduates and one current scholar – to highlight past, present, and future clinical and medical impacts of their research. Example impacts include improved hearing healthcare systems and earlier intervention to improve hearing outcomes, improved quality of life and cancer care for advanced cancer patients and their caregivers, and new approaches to treating urinary symptoms that reduces symptom burden. Collectively, these case studies demonstrate the KL2 Career Development Program's role in developing innovative translational scientists whose work generates meaningful clinical and medical impacts, including improved access to care, enhanced quality of life, and the development of novel therapeutic approaches.

Assessing Clinical and Medical Impact of KL2 Scholars Using the Translational Science Benefits Model: Case Studies from the University of Kentucky Center for Clinical and Translational Science

Kentucky, including Central Appalachia, experiences some of the nation's highest rates of heart disease, cancer, and drug overdose, among other significant health challenges. In response, the University of Kentucky's Center for Clinical and Translational Science (UK CCTS) was established in 2006. Through research funding, training, infrastructure, and community engagement, the UK CCTS fosters innovative team science to address these and other critical health issues among Kentuckians. A key component of the UK CCTS mission is also to supportprogramming that prepares the next generation of clinical and translational researchers.
One such initiative is the KL2 Career Development Program, which provides funding to early-career scientists while supporting them in developing clinical and translational research viastructured coursework, experiential learning, mentored research, team science, and leadership training. The first scholars were awarded funding through the KL2 Career Development Program in 2011. Since then, 26 faculty members have completed the program - 97% of whom graduated from the program having submitted a grant application as Principal Investigator.
Using the Translational Science Benefits Model, this project features case studies of three UK CCTS KL2 Scholars - two graduates and one current scholar - to highlight past, present, and future clinical and medical impacts of their research. Example impacts include improved hearing healthcare systems and earlier intervention to improve hearing outcomes, improved quality of life and cancer care for advanced cancer patients and their caregivers, and new approaches to treating urinary symptoms that reduces symptom burden. Collectively, these case studies demonstrate the KL2 Career Development Program's role in developing innovative translational scientists whose work generates meaningful clinical and medical impacts, including improved access to care, enhanced quality of life, and the development of novel therapeutic approaches.

Assessing the Clinical and Medical Impact of KL2 Scholars Using the Translational Science Benefits Model: Case Studies from the University of Kentucky Center for Clinical and Translational Science

Introduction and Objective: A community leader identified a critical gap in diabetes care among Arab Americans living with Type 2 diabetes (T2D) in Denver, CO. The Arab American population in the US is at increased risk for T2D compared with the non-Hispanic White population with greater insulin resistance among Arab Americans compared with Mexican Americans despite similar body mass indices (BMIs). 

Culturally and linguistically tailored resources for T2D education, particularly Arabic-language resources, remain scarce. Diabetes self-management education and support (DSMES) programs delivered through both live and mobile health (mHealth) modalities have demonstrated improvements in diabetes-related outcomes. Expanding culturally tailored DSMES resources could help address an important gap in diabetes care for Arab Americans.

Furthermore, a genomic study focused on Arab Americans could provide valuable insights in T2D susceptibility and pathophysiology supporting the development of more personalized and culturally responsive approaches to diabetes prevention and management.

Methods: A community-based participatory research (CBPR) framework guides the design and implementation of the intervention, fostering meaningful collaboration between researchers and the community throughout the pilot study. The CTSA collaboration brings together a unique opportunity: 1) a community driven health need, 2) the expertise of a genomics and community engagement team embedded within the Scripps CTSA hub, and 3) training community staff in research techniques.  As part of the dissemination and implementation efforts, evidence-based DSMES programs, Project Dulce, a traditional peer-led and Dulce Digital, a text-based education program, were culturally tailored and delivered in Denver, Colorado, to Arab American communities with T2D. Additionally, a genomic education module was developed and delivered and saliva samples collected after fully informed consent, supporting the study’s broader investigation of genetic factors associated with T2D susceptibility and pathophysiology in the Arab American population.

Results: N=37 participants have been recruited to date.  There are 52% male, mean age of 65.68, and 97% Arabic speaking.  Four peer educators were trained to deliver the DSMES and genomics curriculum and 32 genomic samples were collected.  Full analysis is pending. 

Conclusion:  Diabetes care among Arab Americans can be improved by integrating culturally and linguistically tailored diabetes self-management education and support with genomic education. Guided by a community-based participatory research framework, the study emphasizes meaningful collaboration with community partners and participants while integrating specialized genomic, digital and community engagement expertise from the Scripps CTSA Hub. Findings from this study may provide a foundation for future research in this understudied population.

Bridging the Gap: Leveraging Community Partnerships and CTSA Networks to Address Diabetes Care Differences in Arab Americans

Since 2006, sustained investment from the NIH Clinical and Translational Science Awards (CTSA) Program has enabled the Yale Center for Clinical Investigation (YCCI) to build and progressively strengthen an integrated translational science ecosystem. Across four successive funding cycles (2006–2010, 2010–2015, 2015–2020, and 2020–2026), CTSA-supported infrastructure, community engagement, career development, pilot funding, and interdisciplinary collaboration have expanded Yale's capacity to address persistent translational science barriers, including insufficient trust and trustworthiness, misalignment of research with community health priorities, and limited capacity for community-engaged research. This ecosystem connects community partners with investigators, KL2 scholars, TL1 trainees, and pilot awardees to develop and translate research that addresses community priorities. For this project, the CTSA Administrative leadership, education leadership, and research administration team has assessed notable impact in the Community & Public Health domain of the Translational Science Benefits Model (TSBM), utilizing a comprehensive data set, Flight Tracker, Dimensions AI, and the Yale Clarity AI platform. Scholars were first assessed for the fit of their funded pilot project and career trajectory within the Community & Public Health domain, then evaluated for notable successful products, including publications, grants, inventions, and career roles. The resulting impact extends beyond traditional academic outputs to include stronger community-academic partnerships, improved access to research and health services, enhanced health education and prevention, and implementation of evidence-informed practices. Together, these 20 years of cumulative investment demonstrate how sustained CTSA infrastructure can develop translational scientists, build trusted partnerships, address barriers to translation, and generate measurable benefits for communities and public health. The next phase of Yale’s CTSA investment builds on 20 years of community-engaged translational science by addressing key barriers - including trust and trustworthiness, alignment with community health priorities, research capacity, Yale–community connections, impact assessment, and administrative efficiency. These represent only a focused sampling of priority barriers and targeted initiatives. Stronger partnerships, capacity-building, and intentional measurement will help advance community engagement from participation toward sustained partnership and measurable public health impact. This work will also create a mutually reinforcing connection with the CTSA’s career development and training programs. KL2 scholars and TL1 trainees will gain opportunities to develop community-engaged research skills and contribute to community-identified priorities. Linking barriers to actions, outcomes, and measurable indicators will allow the CTSA to assess whether these investments strengthen partnerships.

Building an Integrated Translational Science Ecosystem to Benefit Public Health  Through Career Development and Community Engagement

As MUSC’s Clinical and Translational Science Award (CTSA) hub, the South Carolina Clinical & Translational Research (SCTR) Institute has played a central role in identifying and overcoming barriers that impede the translation of discoveries into improvements in health. Through a coordinated and collaborative operational model that aligns expertise across research administration, regulatory affairs, workforce development, informatics, and community engagement, SCTR has developed and scaled initiatives that address critical translational bottlenecks. Examples include the Clinical Trialist Training Program, which strengthens the clinical research workforce by equipping investigators with the competencies needed to conduct high-quality clinical research; efforts to expand access to clinical trials through MUSC’s Regional Health Network, bringing research opportunities to rural areas across South Carolina; institutional support for ClinicalTrials.gov registration and reporting compliance, enhancing research transparency and accountability; and implementation of research permissions and opt-out processes that promote ethical participant engagement while facilitating research participation. Together, these initiatives demonstrate how SCTR’s integrated approach advances translational science, expands access to research, strengthens workforce capacity, and generates measurable impacts for patients, communities, and health systems across the state.

BUILDING CAPACITY, ACCESS, AND ACCOUNTABILITY IN TRANSLATIONAL SCIENCE 

Background: 
Since its initial Clinical and Translational Science Award in 2008, the University of Florida Clinical and Translational Science Institute (UF CTSI) has invested in the people, governance, data access, and computational capacity needed to create a translational informatics ecosystem rather than isolated project databases. This poster traces that evolution and assesses its impact using the Translational Science Benefits Model (TSBM), with Clinical and Medical Contributions as the primary domain.

Approach: 
We organized the hub's informatics development across the CTSA era, from the UF Health Integrated Data Repository (IDR) and i2b2 cohort discovery to OneFlorida+, GatorTron, and MySurgeryRisk. We emphasized measurable tools, products, reach, and clinical implementation while distinguishing demonstrated outcomes from future potential.

Impact: 
The IDR grew from more than 46 million observation facts representing approximately 371,000 patients in 2013 to more than 2 billion facts from more than 2 million patients by 2022; internal 2024 reporting described 26,500 governed concepts. OneFlorida+, established in 2015 through a CTSI collaboration, now includes more than 33 million patient records across 19 partner institutions, with data from every Florida county and multi-state partners. GatorTron used more than 82 billion de-identified clinical words from approximately 290 million notes and 2.48 million patients to scale clinical language models to 8.9 billion parameters and improve performance across five clinical NLP tasks; internal 2024 reporting documented 1.3 million model downloads. In a pilot usability study, MySurgeryRisk achieved AUCs of 0.73-0.85 compared with physicians' initial estimates of 0.47-0.69; after interaction with the algorithm, net reclassification improved 12.4% for acute kidney injury and 16% for intensive care unit admission longer than 48 hours.

Conclusion: 
CTSI-supported informatics created complementary "wide" population data and "deep" clinical data linked by common governance, curation, compute, and expertise. This reusable platform has expanded evidence generation and enabled AI-supported clinical decision tools. The next phase will integrate multimodal and high-frequency data with real-time compute and algorithmic vigilance so models can move toward clinical care safely, equitably, and sustainably.

Building the Data-to-Impact Engine

Data methods are foundational to translational research, but moving discovery from clinical settings into real-world contexts requires informatics that assimilates heterogeneous data across institutions, scales, and domains. We describe a sustained Utah Clinical and Translational Science Institute (CTSI) program and assess its outputs and emerging impacts using the Translational Science Benefits Model (TSBM).
In 2010, the Federated Utah Research and Translational Health e-Repository (FURTHeR) was developed to share clinical data across Utah CTSI partners through dynamic federation and on-the-fly transformation. In 2012, this capability was extended through Pediatric Health Information Systems Plus (PHIS+), federating detailed clinical data for more than two million children across six tertiary pediatric centers. The infrastructure enabled comparative effectiveness studies of osteomyelitis treatment, fundoplication versus gastrojejunal feeding, and blood-culture utility in pediatric pneumonia. It was subsequently released as OpenFurther and deployed by other organizations, demonstrating portability and reuse.
Building on CTSI pilots linking air-quality and clinical data, these foundations were adapted in 2019 into the Utah PRISMS Informatics Ecosystem. The ecosystem expanded assimilation beyond health records to sensor, participant-generated, and computationally modeled data, supporting pediatric asthma and Environmental influences on Child Health Outcomes studies. Since 2023, this work has advanced as the Exposure Health Informatics Ecosystem (EHIE), a cloud-based, metadata-driven, multi-scale, multi-model, event-based infrastructure supporting exposome studies across exposure properties, sensors, and study designs. EHIE capabilities have supported studies of diabetes, autoimmune disease, and stillbirth. Current work extends the ecosystem through uncertainty quantification, reusable temporal motifs, machine learning, topological data analysis, agentic artificial intelligence, molecular mimicry, and exposure-aware digital twins.
TSBM mapping identifies the strongest demonstrated benefits in reusable software, biomedical data infrastructure, and evidence informing diagnostic and therapeutic procedures. Emerging community and public-health benefits include resource access, health-care quality and delivery, public-health practice, and disease-prevention capabilities. Broader community, economic, and policy benefits will be assessed through documented adoption, practice change, health outcomes, and decision-maker use. 
This 20-year trajectory shows how sustained CTSA investment can produce a reusable informatics foundation that evolves with translational science, progressing from federated clinical data to molecular, exposure, and real-world evidence, while establishing infrastructure for responsible, exposure-aware digital twins.
Details can be found at: https://ctsi.utah.edu/cores-and-services/bmic/building-the-informatics-foundation-for-translation

Building the Informatics Foundation for Translation: Enabling Real-World Evidence Through Clinical, Molecular, and Exposure Data Assimilation

The CCTS Partner Network provides a powerful translational ecosystem that accelerates the movement of scientific discovery into clinical practice and population health impact by connecting academic medical centers, research institutes, universities, community practices, patients, families, and public health organizations across the Deep South and beyond. Through intentional collaboration, shared expertise, coordinated infrastructure, and a commitment to translation, the Network enhances research capacity and creates the conditions necessary for evidence-based innovations to achieve real-world impact. The CCTS Partner Network serves as a catalyst for discovery and implementation through its contributions to two landmark hypertension studies: the Chronic Hypertension and Pregnancy (CHAP) Trial and the Systolic Blood Pressure Intervention Trial (SPRINT). In both studies, CCTS institutions and investigators played essential roles in multi-site collaboration, participant recruitment, regulatory support, clinical operations, data quality oversight, leadership, and evidence generation. These capabilities enabled rigorous pragmatic research conducted in real-world settings and supported the rapid translation of findings into practice-changing evidence. The impact of this translational model is substantial. Findings from CHAP demonstrated that treating mild chronic hypertension during pregnancy to a blood pressure target of less than 140/90 mm Hg improved maternal and infant outcomes, reduced severe pregnancy complications, and changed standards of care. Similarly, SPRINT established the benefits of intensive blood pressure control, demonstrating reductions in major cardiovascular events and all-cause mortality that informed national and international hypertension guidelines. In both cases, evidence generated through collaborative research moved efficiently from discovery to publication, guideline adoption, clinical implementation, and measurable health improvement. These examples illustrate how the CCTS Partner Network functions as more than a research consortium. It is a strategic translational engine that integrates people, resources, infrastructure, and partnerships to accelerate discovery, strengthen implementation, and ensure that scientific advances rapidly reach the patients and communities that need them most. By bridging research and practice, the CCTS exemplifies how collaborative translational science can drive sustainable improvements in health across the regionally and nationally.

CCTS Collaborative Network: Advancing Discovery to Health Impact

The Center for Biomedical Informatics (CBMI) has established a scalable, CTSA‑aligned informatics ecosystem that accelerates pragmatic clinical trials and real‑world evidence generation across Wisconsin. Through governed, reproducible data access and an integrated research infrastructure, CBMI supports efficient cohort discovery, feasibility assessment, and patient recruitment for investigators and industry partners. This model has produced both outcomes and TSBM impact, specifically in the Clinical & Medical Benefits domain. Specific for Informatics-Driven Clinical Trial, CBMI demonstrated TSBM impact by consistently top‑quartile national recruitment performance across multiple large pragmatic trials, demonstrating reproducible, informatics‑driven enrollment success.  CBMI also developed impact through the development of software technology, OncoLLM. Clinomics, leveraging CBMI’s enterprise research data platform, now supports more than thousands of queries and data exports, enables disease agnostic across clinical specialties. The program has generated substantial scientific output, including peer‑reviewed publications, conference presentations, and support for faculty, trainees, and staff. Clinomics also showcased investigative procedures impact through its OTO Clinomics. With 8 partner institutions and expanding statewide presence, CBMI is advancing Wisconsin’s research data future by connecting investigators to research‑ready data, tools, and expertise, demonstrating trial acceleration, workforce development, and transformative research impact. 

Center for Biomedical Informatics (CBMI) Accelerating Research Excellence

Background: The Vanderbilt Center for Learning Healthcare conducts pragmatic comparative-effectiveness trials embedded in routine care. Assessing their impact requires evaluating the broader benefits generated for patients, clinicians, health systems, and communities.
 
Methods: We applied the Translational Science Benefits Model (TSBM) to the Center’s trial-prioritization framework and to an impact profile of the Randomized Trial of Sedative Choice for Intubation (RSI). The RSI trial was a pragmatic, comparative effectiveness trial in which patients were randomized to receive either etomidate or ketamine as the sedative medication during emergency tracheal intubation. The primary outcome was 28-day mortality, and the secondary outcome was cardiovascular collapse. The research team, program staff, and community members identified demonstrated and potential benefits of the RSI trial across the TSBM domain of clinical and medical benefits. 
 
Results: CTSA support enabled a Learning Healthcare System Platform that provides shared governance and infrastructure for conducting transdisciplinary pragmatic trials. The Center’s criteria for prioritizing trials—clinical and operational importance, timeliness and feasibility of the research question, institutional commitment to dissemination and implementation, and the resource impact of acting on results—mapped directly to opportunities for impact across three of the four TSBM domains. The RSI trial enrolled 2,365 adults undergoing emergency tracheal intubation at 14 U.S. emergency departments and intensive care units. Twenty-eight-day mortality was similar with ketamine and etomidate, but ketamine increased cardiovascular collapse (22.1% vs 17.0%); thus, using etomidate rather than ketamine would prevent approximately one episode for every 20 patients treated. Demonstrated clinical and medical benefits included patient-guided research, a published approach to community consultation and public disclosure, and evidence informing sedative choice during emergency intubation. Incorporation of the findings into UpToDate represented a potential guideline benefit. Following dissemination, clinician practice shifted toward use of etomidate at Vanderbilt and across the Pragmatic Critical Care Research Group.
 
Conclusions: The TSBM provides a practical framework for evaluating the realized and future impact of pragmatic trials conducted by the Center for Learning Healthcare. 



Center for Learning Healthcare: Evaluating Pragmatic Trials Through the Lens of the Translational Science Benefits Model 

The Clinical and Translational Science Awards (CTSA) Program was established to accelerate translational science through collaboration, innovation, and dissemination. While Clinical and Community contributions are frequently recognized through downstream outcomes such as improvements in healthcare quality, healthcare delivery, community partnerships, and patient-centered research, less attention has been given to the upstream conditions that enable these benefits to emerge. One such condition may be cross-hub collaboration.

This poster examines cross-hub collaborations spanning Team Science, Mentorship, Rural Engagement, Evaluation, and Dissemination & Implementation. Across these domains, a common pathway is observed: collaboration generates products such as credentials, interventions, training programs, frameworks, communities of practice, evaluation methods, and learning health system approaches. Through dissemination and implementation, these products are shared, adopted, adapted, and sustained across institutions, extending their reach beyond the originating hub.

Collectively, these collaborations strengthen translational science capacity by developing workforce competencies, interdisciplinary networks, implementation expertise, evaluation systems, and relationships necessary to move discoveries into practice. We propose a conceptual model in which Collaboration → Product → Dissemination → Implementation → Broader Impact → Clinical and Community Benefits. Within this framework, dissemination and implementation serve as critical mechanisms linking collaborative products to real-world adoption and use.

Rather than viewing collaborations solely as activities, we posit that they function as upstream translational science investments that increase the likelihood, scale, sustainability, and reach of downstream benefits. By strengthening the systems, networks, and infrastructure that support translational science, cross-hub collaborations may contribute to improved healthcare quality, healthcare access, healthcare delivery, community partnerships, and patient-guided research.
Future research should examine whether cross-hub collaborations accelerate the magnitude, timing, scale, and sustainability of downstream translational science benefits, and whether collaboration itself should be considered a distinct pathway to impact within the CTSA ecosystem.

Clinical & Community Contributions Through Cross-Hub Collaboration

In keeping with the theme "20 Years of CTSA Impact - Past, Present, and Future," and representing the clinical and medical contributions domain of the Translational Science Benefits Model (TSBM), this poster illustrates the history and impact of our clinical research unit network from 2006-2026. In 2006, The University of Texas Health Science Center at Houston (UTHealth Houston) was one of 12 inaugural recipients of the Clinical and Translational Science Award (CTSA), a newly launched initiative developed by the National Institutes of Health (NIH). Included in the award were partner institutions The University of Texas MD Anderson Cancer Center and Memorial Hermann Hospital-Texas Medical Center. Under the CTSA, the organizations worked together to establish the Center for Clinical and Translational Sciences (CCTS). Located in the Texas Medical Center—the largest medical complex in the world—the CCTS brought the existing clinical research units (CRUs) at UTHealth Houston (housed at Memorial Hermann Hospital) and UT MD Anderson Cancer Center into the fold. Another CRU, still in its infancy at the UTHealth Houston School of Public Health in Brownsville, was also added. Today, the CCTS provides infrastructure, support, and resources for multiple CRUs spanning the entire state of Texas, encompassing a catchment area that includes more than 12 million Texans and represents remote, rural, and densely populated areas. The next facility is scheduled to launch in late 2026, in Laredo, Texas. To continue to develop translational science, active CRUs are necessary to conduct multi-disease research. The expansive CRU network of the CCTS provides patients and clinical research studies with increased resources, modern facilities, and advanced infrastructure resulting in more populations served and greater impact for all of Texas and beyond. 

Clinical Research Units: Our Impact Roadmap

Background: Rural adults experience disproportionately high rates of cigarette smoking while facing barriers to digital health participation, including limited broadband, lack of internet-enabled devices, and variable digital literacy. The IDEA Study tested strategies to promote engagement with digital evidence-based cessation treatment (EBCT) resources among rural adults. We applied the Translational Science Benefits Model (TSBM) to assess the study’s broader impact beyond traditional trial outcomes. 

Methods: Using a community-based participatory research approach, a Midwest rural advisory committee informed study design, recruitment, intervention materials, and dissemination. Rural adults participating in a randomized pilot trial received a 12-week portal-based cessation program and one of three digital-access strategies: (1) printed materials on accessing the internet; (2) printed materials plus a loaner cellular-enabled iPad; or (3) printed materials, a loaner device, and up to six brief digital literacy coaching calls. Trial outcomes and interviews assessed treatment response and acceptability. TSBM was used to characterize impacts across Clinical & Medical, Community & Public Health, Economic, and Policy & Legislative domains and influence on subsequent research. 

Results: Coaching was significantly associated (p<0.05) with improved smoking-related treatment response, including cigarette abstinence and digital EBCT resource use. TSBM assessment demonstrated impacts extending beyond trial outcomes across all TSBM domains including Community & Public Health, Economic, and Policy & Legislative, with key benefits demonstrated in the Clinical & Medical benefits domain. Clinical & Medical benefits included demonstration of patient-centered intervention strategies supported smoking cessation outcomes and the use of a digital health screening tool, which is proposed for integration into the electronic medical record. Literacy coaching and digital inclusion strategies have potential to impact clinical and medical guidelines and implementation. Study resources and workflows were adopted by subsequent projects and supported new externally funded research. 

Conclusions: TSBM demonstrated that IDEA’s impact extended beyond its primary endpoint to practical tools, research infrastructure, implementation strategies, and potential clinical, public health, economic, and policy benefits. IDEA illustrates how TSBM can capture the multidimensional impact of translational research and how addressing digital inclusion can generate benefits extending to future research, clinical care, and rural communities.

Closing Rural Digital Care Gaps: The IDEA Study as a Model for Digitally Inclusive Rural Health Research

Despite significant advances in cardiovascular (CV) prevention and treatment, health outcomes in the U.S remain unevenly distributed. Houston exemplifies this challenge with marked variation in CV disease burden and life expectancy across neighborhoods. Healthcare systems, public health agencies, community organizations, and academic institutions each contribute to population health (PH) improvement, however, these sectors often operate independently, limiting the translation of evidence-based interventions to population-scale impact. The Consortium for Translational and Precision Health (CTPH), a Clinical and Translational Science Award (CTSA)-supported partnership, is addressing this gap through a citywide precision population health initiative focused on hypertension and CV disease prevention. 
Building on the global CV health program Cardio4Cities (C4C), this initiative establishes a cross-sector implementation model that aligns healthcare organizations, public health agencies, community-based organizations, and academic partners around shared CV health objectives. A central innovation is the application of precision population health principles to translational science. The model integrates multimodal clinical, community, and neighborhood-level data to support population health surveillance, risk stratification, implementation planning, and performance monitoring.  Precision prevention strategies are matched to local needs, while closed-loop precision referral pathways link healthcare systems and community services. Precision implementation approaches are used to tailor strategies to organizational capacity, community context , and emerging performance data.
The initiative employs implementation science methods adapted for precision PH, including the C4C and PRISM frameworks, implementation facilitation, coalition building, community navigation, and continuous quality improvement to support sustainable scale-up and reach. Early translational impacts include creation of a multi-sector governance structure; development of a shared PH data infrastructure; creation of coordinated implementation and evaluation processes; engagement of healthcare: unified partner engagement approach; and indicators of hypertension prevention and control. 
Impact Statement: By serving as the implementation backbone for a city-wide population health initiative, CTPH demonstrates how public-private partnerships can close the "last mile" between scientific discovery and community health improvement. This work advances a scalable translational science model for precision PH that can be adapted by other CTSA hubs seeking to accelerate community and PH impact. 



Closing the Last Mile of Translation to Precision Population Health: A Model for Community Cardiovascular Health Improvement

The CTSA Program has a growing evidence base for measuring impact, including the CTSA Measures Concept Mapping Project and the Translational Science Benefits Model (TSBM). Building on these frameworks, this study asked: Which impact measures do hubs use, value most, and can realistically collect?

In 2025–2026, the National Administrators and Evaluators groups jointly created and fielded the CTSA Impact Measures Leadership Survey, a five-question instrument approved by the CTSA Steering Committee. One coordinated response was requested from each hub, with parallel responses from NCATS Program Officers and Executive Leadership. Respondents rated seven Concept Mapping measures and all 24 TSBM measures on current use, value, and feasibility. More than 125 open-text responses were independently coded by CTSA administrators, evaluators, and NIH OPEAR staff.

100% of CTSA hubs (n=65) and NCATS stakeholders (n=19) responded, establishing a comprehensive consortium benchmark for impact measurement. Results showed broad agreement on the measures viewed as most valuable, alongside important differences in feasibility. Clinical and medical measures were viewed as highly feasible, while economic and longer-horizon population health measures were more difficult to collect. Policy measures were notable for their combination of high value and feasibility. Comparisons between hubs and NCATS identified areas of convergence and divergence in priorities and perceptions of feasibility. Qualitative findings highlighted additional needs related to institutional impact, workforce and career development, infrastructure,  collaboration, and population health.

The survey establishes a national baseline of impact-measurement practice and provides actionable information and benchmarks for hub leadership and future consortium-level work. Findings underscore the importance of considering value and feasibility together when developing sustainable impact-measurement strategies.

Consortium Benchmarks for Measuring Impact: Findings from the National Impact Measures Survey

Purpose: The Translational Science Benefits Model (TSBM) was developed to help clinical and public health researchers identify, document, and communicate the real-world impact of their work. Since 2017, it has evolved from a conceptual framework into a practical approach for assessing translational impact across four domains: clinical, community, economic, and policy. This poster demonstrates how the TSBM can be applied across levels of research, from individual projects to programs, institutions, and research networks.

Application: The TSBM supports researchers in planning for, tracking, and demonstrating impact throughout the research process. The Translating for Impact Toolkit provides nine free online tools to identify potential benefits, document evidence, and develop products for communicating impact. The framework can also be applied across portfolios of projects to aggregate evidence and characterize collective impact.

Demonstration: Existing applications illustrate the framework’s adaptability. Investigators have used TSBM Impact Profiles to summarize project benefits and supporting evidence, while research networks have mapped activities and outputs to the 40 TSBM benefits to develop portfolio-level impact reports. These applications illustrate how the TSBM can be adapted to assess impact from individual projects to broader research portfolios.

Implications: The TSBM offers a systematic approach for moving beyond traditional academic outputs to capture the broader value of translational research. Its application across projects and portfolios can strengthen impact assessment, support aggregation of evidence, and improve communication of research contributions to health, health systems, and communities.


Demonstrating Project and Program Impact using the Translational Science Benefits Model (TSBM)

Storytelling plays a powerful role in influencing perceptions, knowledge, and behaviors around medicine and healthcare. Less is known about its influence on research attitudes. The overarching aims of this multi-part initiative, in collaboration with the Norman Lear Center, are to characterize the current landscape of medical advancement topics and issues depicted in popular entertainment media, to capture changes in these depictions over time, and to investigate the influence of these portrayals on viewers’ attitudes toward research. Highlighted findings include: 1) The frequency of “clinical trial” and related keywords has increased in English-language scripted entertainment from 2016 (2.2% of episodes and films) to 2024 (4.7%), overwhelmingly in dramas. 2) In a sample of 100 episodes mentioning clinical trials, the majority portrayed them as trustworthy; however, a substantial minority included untrustworthy story elements such as researchers lying or withholding information or selecting participants unfairly. 3) A clinical trial storyline on a 2026 episode of Grey’s Anatomy was associated with significantly greater willingness to participate in clinical trials among viewers, compared to a control storyline from the same episode. 4) Interest in visiting a clinical trials website displayed after the storyline was higher after viewing a “hopeful” version of the trial storyline compared to control, but not after viewing a “negative” version. 5) Greater identification with the patient and clinician-scientist characters was significantly associated with more favorable feelings toward clinical trials and greater behavioral intentions. 6) Findings from focus groups about the storyline further suggest that trust and identification with characters may shape how audiences interpret these narratives. These findings suggest that engaging storylines depicting medical advancements, particularly those emphasizing trustworthy and hopeful narratives, can meaningfully enhance public attitudes and willingness to participate in clinical research.

Depicting Clinical Trials in Film and Television: Analysis of the Landscape and Exploration of Opportunities for Increasing Research Participation 

Design and Impact of a Translational Science Pilot Grant Program: Application of the Translational Science Benefits Model Framework

We transformed the Michigan Institute for Clinical & Health Research (MICHR) Pilot Grant Program in response to the CTSA shift to support translational science (TS). Since March 2023, we have launched four 1-year cycles of pilot grant funding and are preparing for the fifth cycle. The transition to TS represented a major mindset shift for the University community. To address this, we built in education and personalized guidance starting at the pre-application stage, including introduction to the TSBM. We also added a structured Letter of Intent (LOI) requirement to increase alignment of proposed projects with translational science. MICHR partners with pilot grant awardee teams throughout the project lifecycle, with funded projects handled as mini cooperative agreements. The TSBM framework is utilized throughout, including at the project reporting stage in pilot awardee portfolios.

Based on 14 pilot projects conducted during the first three funding cycles (March 2023 – February 2026), 74 indicators of demonstrated or potential benefits were reported across the 4 TSBM domains. The majority of indicators were in the Clinical & Medical (15 demonstrated, 9 potential) and Community & Public Health domains (11 demonstrated, 14 potential) and were distributed across several sub-categories (displayed by weighted circles in the corresponding figure). For the Economic and Policy domains, a higher proportion of benefits were classified as potential compared to demonstrated, which is expected given that these domains largely reflect longer-term outcomes that are less likely to be attained during or shortly after the one-year pilot project period.


Over four decades, clinical trials based on detailed mechanistic studies of human skin transformed psoriasis from a broadly treated inflammatory disease into one managed with therapies targeting specific immune pathways. Researchers identified the IL-23/IL-17 pathway, tested targeted biologics, measured molecular changes in treated skin, and translated these findings into FDA-approved therapies. This poster uses the Translational Science Benefits Model to show how discoveries moved repeatedly between the laboratory and the clinic. The same research framework also advanced other diseases, but each has its own mechanistic drivers. In atopic dermatitis, human studies validated IL-4/IL-13 signaling and supported the successful use of dupilumab. In hidradenitis suppurativa, tissue profiling and clinical studies helped establish IL-17 as a therapeutic target.

Discovery of the Immunologic Drivers of Psoriasis Through Human Studies Leads to a Paradigm Shift in Understanding its Pathogenesis and Revolutionary New Therapies, Creating a Model that Extends to Atopic Dermatitis and Hidradenitis Suppurativa

Over two decades, the University of Iowa Institute for Clinical and Translational Science (ICTS) has built statewide systems designed to improve research participation and healthcare delivery across Iowa, particularly in rural communities. To illustrate this, we present a Sankey diagram demonstrating how programs based on our three strategic aims led to impact across the Translational Science Benefits Model. Highlights in clinical and medical contributions show how investment in research infrastructure, workforce, and data resources accelerates taking scientific discovery into practice. 

Aim 1: Create New Methods and Tools to Move Research Participation, Data Collection, and Interventions from the Clinic to the Home. ICTS programs reduce barriers to clinical research and expand access to clinical care for geographically dispersed and inadequately resourced populations through statewide partnerships and data/technology-enabled resources. Programs like the SMART-OASIS app; Technology-enabled Medication Safety in Schools; Birth to Three-Cavity Free; and the IRENE Practice-Based Research Network (PBRN), strengthen research engagement, partnerships, and execution of evidence-based guidelines across communities.  

Aim 2: Develop the Workforce Needed to Catalyze Innovative Science. ICTS programs build and champion a multidisciplinary workforce that meets unique needs across Iowa. The Iowa Mentoring Academy, Clinical Trials Investigator Bootcamp, and Academy for Research Professionals promote competencies across disciplines and career stages. ICTS’ multi-level approach to workforce development provides ongoing support of research professionals, students, and faculty, enforcing proficiency in clinical research methods, and literacy in application of clinical and translational science tools for research and discovery. 

Aim 3: Promote an Innovative, Integrated Framework for Conducting Clinical and Translational Research. ICTS’ enterprise research ecosystem is sustained through investment in a framework of data-rich resources. The Iowa Health Data Resource (IHDR), ICTMS, TriNetX and related platforms establish a series of data networks and secure data environments to support health informatics research and facilitate access to complex clinical and population-level data. These efforts accelerate study activation and recruitment, strengthen shared decision-making, and support statewide engagement. ICTS also leads the national Research Unit Network (RUN), who are using data to develop a maturity model to advance best practices and the safe conduct of clinical research. 

ICTS programs continue to generate impact by reducing barriers to research through increased efficiency in participant enrollment, technology-enabled solutions, scalable data resources that support large-scale research, and innovative approaches to workforce development. Collectively, these resources amplify what we can do to advance science and health in the state of Iowa and beyond.

Discovery to Impact: 20 Years of Advancing Translational Science for Iowa and Beyond 

Newborn screening (NBS) is a highly effective public
health program; however, a persistent translational science
challenge exists for rare genetic conditions: evidence is
required before new conditions can be added to screening
panels, yet population-scale evidence is difficult to generate
without screening large numbers of newborns. Early Check
was developed in North Carolina to address this evidence gap
and create a research infrastructure capable of evaluating
promising conditions and emerging genomic technologies
within a real-world NBS setting.

Early Check:  Advancing Newborn Screening in North Carolina

Most researchers receive little formal training communicating their research to non-scientific audiences, and many community members report never receiving the results of studies in which they participated.
We developed the one-month TRIumph Communication Program in 2024 to help our CTSA supported researchers and trainees bridge the communication gap between translational science experts and the community. 
TRIumph provides a structured curriculum emphasizing clear, audience-centered communication, macrostructure, preparation, practice, and feedback in which participants learn how to communicate their research clearly and confidently to community audiences. Macrostructure is a key skill taught in this program to help presenters build a concise and memorable presentation. It consists of an attention-getting introduction to build speaker credibility and the goal of the presentation; a body with main points and relevance statements; and a strong conclusion that restates the thesis, reviews the main points, and closes the presentation by tying in the attention-getting statement from the introduction.
Additionally, the curriculum focuses on developing knowledge about public speaking by focusing on the core principles of speaking positively in public Prior to any coursework, pre-tests were given to all participants to measure baseline public speaking knowledge, public speaking competence, and speaking apprehension.  At the conclusion of the training, post-assessments were administered to all participants. Overall, across the 2025 and 2026 cohorts, participants increased their public speaking knowledge by 12.1%, their public speaking competence by 9.4%, and reduced their public speaking apprehension by 6.4%. 
The presentations generated by TRIumph participants were successful in engaging the target communities. At the final 10-minute in-person presentation, rating forms were completed by audience members which included community members, program peers, and program faculty and staff.  Audience members rated each speaker on their use of accessible language focusing on whether the presentation was easy to understand; the speaker used words that made sense; and the degree to which the presentation had a clear message that stuck. Ratings were captured using Likert scales where 1 was Strongly Disagree, 3 was Neutral, and 5 was Strongly agree. Across the 2025 observations, the average rating of these criteria was 4.21, and for 2026 it was 4.64. In addition, TRIumph program graduates report that the program positively impacted their subsequent approach to communication and presentations, even to expert audiences.  


Effectiveness of TRIumph Communication Program on K12 and T32 Trainee Communication Competency

Introduction
Clinical research has long struggled with inadequate inclusion in study populations, limiting the generalizability of findings. Despite incremental progress, groups in the U.S remain underrepresented in research. Large-scale observational research collaboratives offer a promising avenue to address this gap. Safety-net health systems often care for groups of underrepresented patients who face numerous barriers to participation. Leveraging a repeatable, efficient process developed by The University of Texas Southwestern Medical Center (UTSW), Parkland Health implemented the open community Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to enhance representation in future studies.

Methods
Parkland Health is a large, safety-net health system caring for underserved populations. To foster collaborative research among partner institutions in North Texas, the UTSW Clinical and Translational Science Award (CTSA) Program supported broad adoption of the OMOP CDM, which allows de-identified aggregation of standardized analyses from federated, interoperable health databases. By leveraging Epic’s native Caboodle extract, transform, and load (ETL) infrastructure, UTSW developed a repeatable and scalable pathway for OMOP CDM implementation across Epic-based health systems. In partnership with UTSW and Texas Health Resources (THR), Parkland implemented the OMOP CDM using UTSW’s novel approach. Following implementation, the sites queried known underrepresented populations in the OMOP person table and aggregated counts for the three largest groups.

Results
Parkland successfully implemented the OMOP CDM in September 2025 using UTSW's portable Epic-to-OMOP framework. Total implementation effort was only 30 hours of programming work, demonstrating the feasibility of OMOP adoption in a resource-constrained safety-net setting. Following implementation, standardized OMOP queries were executed consistently across participating institutions, including a semaglutide use case, demonstrating the portability of the implementation model and cross-system analytic interoperability. Parkland's OMOP CDM population was comprised of 23% Black/African American and 46% Hispanic patients, compared with UTSW (13% and 25%, respectively). Together, the participating health systems contributed more than 8 million patients to a shared OMOP-based research ecosystem with 1.3 million Black/African American and 2.7 million Hispanic patients.

Conclusion
UTSW's portable Epic-to-OMOP approach enabled Parkland to efficiently implement a standardized, query-able OMOP environment using minimal resources. By reducing implementation effort to 30 hours and incorporating a large, safety-net population into a federated research network, this model broadens representation in observational research and represents a scalable pathway for OHDSI-based collaboration. Efforts to add social determinants of health data into the CDM are underway to enhance research impact.


Enabling OMOP in Safety-Net Health Systems Broadens Observational Research Populations

Introduction
Clinical research has long struggled with inadequate inclusion in study populations, limiting the generalizability of findings. Despite incremental progress, groups in the U.S remain underrepresented in research. Large-scale observational research collaboratives offer a promising avenue to address this gap. Safety-net health systems often care for groups of underrepresented patients who face numerous barriers to participation. Leveraging a repeatable, efficient process developed by The University of Texas Southwestern Medical Center (UTSW), Parkland Health implemented the open community Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to enhance representation in future studies.

Methods
Parkland Health is a large, safety-net health system caring for underserved populations. To foster collaborative research among partner institutions in North Texas, the UTSW Clinical and Translational Science Award (CTSA) Program supported broad adoption of the OMOP CDM, which allows de-identified aggregation of standardized analyses from federated, interoperable health databases. By leveraging Epic’s native Caboodle extract, transform, and load (ETL) infrastructure, UTSW developed a repeatable and scalable pathway for OMOP CDM implementation across Epic-based health systems. In partnership with UTSW and Texas Health Resources (THR), Parkland implemented the OMOP CDM using UTSW’s novel approach. Following implementation, the sites queried known underrepresented populations in the OMOP person table and aggregated counts for the three largest groups.

Results
Parkland successfully implemented the OMOP CDM in September 2025 using UTSW's portable Epic-to-OMOP framework. Total implementation effort was only 30 hours of programming work, demonstrating the feasibility of OMOP adoption in a resource-constrained safety-net setting. Following implementation, standardized OMOP queries were executed consistently across participating institutions, including a semaglutide use case, demonstrating the portability of the implementation model and cross-system analytic interoperability. Parkland's OMOP CDM population was comprised of 23% Black/African American and 46% Hispanic patients, compared with UTSW (13% and 25%, respectively). Together, the participating health systems contributed more than 8 million patients to a shared OMOP-based research ecosystem with 1.3 million Black/African American and 2.7 million Hispanic patients.

Conclusion
UTSW's portable Epic-to-OMOP approach enabled Parkland to efficiently implement a standardized, query-able OMOP environment using minimal resources. By reducing implementation effort to 30 hours and incorporating a large, safety-net population into a federated research network, this model broadens representation in observational research and represents a scalable pathway for OHDSI-based collaboration. Efforts to identify health determinants (biology, structural, and social) within the CDM are underway to enhance research impact

The ENACT platform is the largest collaborative research computing environment using real-world data from the electronic health record (EHR) – a platform built by researchers, for researchers. ENACT supports research using vast amounts of EHR data, clinical decision-making, natural language processing (NLP), and artificial intelligence (AI), including machine learning (ML). Initially created as a federated EHR network built on a foundation of trust, with >50 Clinical and Translational Award hubs providing >142 million harmonized patient records and a data quality program, ENACT is designed for research across virtually every disease. Key features of ENACT include: desktop cohort discovery for assessing study feasibility, EHR research using patient counts from millions of records, NLP capability to extract concepts from clinical notes, ephemeral enclaves for AI/ML analytics, and a clinical evidence service. To deliver unique functionality and inform future plans, ENACT created an informatics community, including 45 national informatics experts from 16 institutions, convened in 7 workgroups to provide expertise that supports the development of real-world evidence from real-world data. Use cases for key ENACT resources include:

ENACT Real World Evidence (RWE) Hub: Clinicians often lack access to timely, patient-specific evidence at the point of care, especially when existing guidelines and literature are insufficient for making informed decisions. To address this challenge, ENACT launched the RWE Hub, where clinicians submit questions to the RWE team. ENACT then provides evidence derived from aggregated patient counts from the ENACT network. The team formulates and executes queries using the SHRINE tool, which enables interactive querying of the EHRs or, in some cases, claims data. The RWE team analyzes the data and prepares an evidence-based report for the clinician, who can share it with patients to support shared decision making. The use of AI to automate the workflow and increase throughput are now available for some queries. 

ENACT Hub Trusted Research Environment program: Translational researchers need ready access to EHRs across multiple institutions for the specific cohorts. To address this gap, ENACT launched the Hub Trusted Research Environment program, which creates ephemeral enclaves—dedicated virtual workspaces for analyzing limited datasets from participating ENACT sites. Research teams formulate research questions and run queries in the SHRINE tool to identify suitable cohorts. Based on the identified cohort, the ENACT enclaves’ team securely transfers limited patient-level datasets from participating ENACT sites to a secure cloud-based enclave. Members of the research team securely log in to the enclave and use familiar tools such as Jupyter Notebooks, Python, and R to perform sophisticated analyses, including AI/ML............

ENACT: Cohort Discovery, Research, and Clinical Decision Support

The ENACT platform is the largest collaborative research computing environment using real-world data from the electronic health record (EHR) – a platform built by researchers for researchers. ENACT supports research using vast amounts of EHR data, clinical decision-making, natural language processing (NLP) and artificial intelligence (AI), including machine learning (ML). Initially created as a federated EHR network built on a foundation of trust with >50 Clinical and Translational Award hubs providing >142 million harmonized patient records and a data quality program, ENACT is designed for research across virtually every disease. Key features include: desktop cohort discovery for assessing study feasibility, EHR research using patient counts from millions of records, NLP capability to extract concepts from clinical notes, ephemeral enclaves for AI/ML analytics and a clinical evidence service. To deliver unique functionality, inform future plans and support the development of real-world evidence from real-world data, ENACT created an informatics community with 45 national informatics experts from 16 institutions convened in 7 workgroups. Use cases for key ENACT resources include:

ENACT Real World Evidence (RWE) Hub: Clinicians often lack access to timely patient-specific evidence at the point of care, especially when existing guidelines and literature are insufficient for making informed decisions. To address this challenge, ENACT launched the RWE Hub, where clinicians submit questions to the RWE team. ENACT provides evidence derived from aggregated patient counts from the ENACT network and formulates and executes queries using the SHRINE tool, which enables interactive querying of the EHRs or, in some cases, claims data. The RWE team prepares an evidence-based report for the clinician, who can share it with patients to support shared decision making. The use of AI to automate the workflow and increase throughput are now available for some queries. 

ENACT Hub Trusted Research Environment program: Translational researchers need ready access to EHRs across multiple institutions. To address this gap, ENACT launched the Hub Trusted Research Environment program, which creates ephemeral enclaves—dedicated virtual workspaces for analyzing limited datasets from participating ENACT sites. Research teams formulate research questions and run queries in the SHRINE tool to identify suitable cohorts. Based on the identified cohort, the ENACT enclaves’ team securely transfers limited patient-level datasets from participating ENACT sites to a secure cloud-based enclave. Members of the research team securely log in to the enclave and use familiar tools such as Jupyter Notebooks, Python, and R to perform sophisticated analyses, including AI/ML. This enables EHR-based research on any disease. Limiting the data lifespan in the ephemeral enclave to what the study requires has been crucial to gaining the trust of participating healthcare systems.

Since its inception in 2007, the Institute of Translational Health Sciences (ITHS) based at the University of Washington (UW) has worked with its partners to build capacity for clinical trials. Early investments from the CTSA program and UW Medicine strengthened the development of resources such as dedicated clinical space in the main hospital, research nursing that could be deployed to inpatient or outpatient units, and flexible research coordination and regulatory staffing. In 2018, ITHS and UW Medicine established UW’s Clinical Trials Office (CTO) to standardize and centralize clinical trial support across the organization. The CTO provides multi-service support to clinical researchers bringing important new therapies to patients while maintaining compliance with evolving regulatory and institutional requirements. 

Leveraging the clinical trials management system (CTMS), the CTO has defined metrics and developed real-time dashboards that have expedited identification of bottlenecks and process improvement opportunities. For example, clinical trial agreements (CTAs) and pre-clinical trial confidentiality disclosure agreements (CDAs) were managed by a central UW office responsible for all contract review at the institution. After initial pilots, CTA and CDA negotiation was transferred to the CTO, reducing time to completion by more than 80%. Additional changes—including streamlining processes, automating and parallelizing workflows, and reducing handoffs—have contributed to reducing study start-up time by 40% over the past 8 years. Meanwhile, annual new clinical trial volume has grown by 46% and total clinical trial submissions, including amendments, have increased by 87%. Improved start-up efficiencies have attracted a growing number of industry-sponsored trials in recent years.

The UW CTO has improved negotiations of feasible budgets, consolidated and centralized services, and accelerated trial start-up times while maintaining appropriate compliance standards. Reducing clinical trial start-up timelines is more than an operational target or achievement. It means that patients gain earlier access to promising new therapies, and physicians have more treatment options for complex diseases. The CTSA program alongside ongoing strategic investments from UW Medicine are making more clinical trials available to patient communities.

Faster translation through clinical trial efficiencies: building effective centralized clinical trial support 

Background: The Trial Innovation Network (TIN), a partnership funded by the National Center for Advancing Translational Sciences (NCATS) within the Clinical and Translational Science Award (CTSA) program, addresses critical challenges in multi-site clinical research. By leveraging the extensive national CTSA infrastructure, its network partners, and fostering collaboration, the TIN accelerates the translation of innovative research into therapeutic solutions. This poster illustrates the TIN pathway from idea to dissemination
Methods: Two Trial Innovation Centers (Johns Hopkins University, Vanderbilt University Medical Center) and one Recruitment Innovation Center (Vanderbilt University Medical Center) provide no cost consultation services for multicenter studies, connecting clinical investigators with domain experts, strategic partners, and leveraging the entire CTSA network to optimize trial design and operational efficiency. The TICs and RIC have formed partnerships with more than a dozen CTSAs to enhance and strengthen the TIN consultation experience. 
Results: By working closely with investigators, the TICs and RIC have provided resources and facilitated numerous successful consultations across the TIN. They have been able to embed and test their innovations into the clinical trials that come through the TIN proposal and consultation process
Conclusion: The TIN offers a sustainable model for overcoming barriers in multisite clinical trials with innovative solutions, supporting the future optimization of clinical research.


From Concept to Dissemination – Advancing Clinical Trial Innovations

Background: Frailty is an important predictor of adverse outcomes among older adults, yet implementing frailty screening at scale remains challenging, particularly outside geriatric specialty care. Electronic frailty indices (eFIs), derived from routinely collected electronic health record (EHR) data, provide a scalable approach to identifying vulnerable patients. In 2017, the Wake Forest Clinical and Translational Science Institute (CTSI) supported development of an eFI through a CTSA pilot award.
Translational Approach: The CTSA-supported project developed and evaluated an EHR-based eFI designed to identify frailty using routinely collected clinical data. The eFI was integrated into the EHR in 2019 and subsequently incorporated into the Atrium Health Epic (Encompass) environment. This transition moved the eFI from a research innovation into clinical infrastructure capable of identifying frailty across a large integrated health system.
Downstream Impact: The eFI is now integrated throughout Atrium Health, spanning more than 40 hospitals, enabling identification of vulnerable older adults within routine clinical care. The tool has been used to identify patients who may benefit from targeted services and changes in medical management, including nurse navigation, pre-operative assessment, post-skilled nursing facility follow-up, individualized A1c target review, oncology and advance care planning studies, and palliative care outreach. The eFI has also generated substantial downstream research, with more than $2.2 million in subsequent grant awards and a growing body of peer-reviewed publications.
eFI implementation has also influenced Atrium Health's approach to the CMS Age-Friendly Healthcare Systems requirements and has supported broader dissemination of electronic frailty screening, complemented by parallel national implementation within the U.S. Veterans Health Administration and the United Kingdom's National Health Service.
Translational Science Benefit: The eFI demonstrates how CTSA investment can move an innovation beyond research publication to become a scalable clinical technology with health-system, policy, and international impact. Within the Translational Science Benefits Model, the primary benefit is Clinical & Medical – Software Technologies. The eFI illustrates a pathway from CTSA-supported research to EHR integration, health-system-wide implementation, changes in approaches to age-friendly care, and broad dissemination. This represents a tangible example of translational science producing sustained impact in clinical care and beyond.

From CTSA Pilot Funding to Health System-Wide Impact: Translating the Electronic Frailty Index (eFI) into Clinical Practice

Background: The NIH’s Clinical and Translational Science Awards (CTSA) consortium aims to accelerate the translation of research discoveries into health impacts, such as advances in evidence-based clinical practices. Portfolios of published findings can help us understand how program activities lead to translational outcomes. These publications can lead to clinical impact through their use in clinical guideline documents, which advise practitioners and patients in health-related decision-making. Using state-of-the-art bibliometrics, we evaluated how research supported by the CTSA program has been translated beyond academic boundaries to inform clinical guideline formulation.
Process: Using PubMed and NIH RePORTER, we identified 160K publications supported by the CTSA consortium from 2006 to 2026. We queried those publications in the Overton Policy Database, for references in clinical guidelines documents, which are written primarily by or for clinicians from health-related policy organizations. We evaluated content and characteristics for both the referenced CTSA-supported research and the referencing clinical guidelines documents.
Findings: Approximately 14K (9%) CTSA-supported publications were referenced in clinical guidelines.  Research with higher academic influence, public attention, and clinical relevance was significantly more likely to be referenced in a clinical guideline. Those publications were referenced 30K times in 13K different clinical guideline documents authored by 71 organizations across 24 countries. The most frequent outlets were Guidelines in Pubmed Central, the Centers for Disease Control and Prevention, and other national health agencies around the world. Referencing clinical guidelines were most often comprised of evidence syntheses on the topics of Infectious Diseases (esp COVID-19 & antimicrobial stewardship), Pediatrics/ Neonatology, Cancer/Oncology, and Women’s & Maternal/Fetal Health. Research publications were referenced in 2.1 clinical guidelines on average (range = 1-106, SD = 3)), and the interval from publication to its first clinical guideline reference was 3.1 years on average (range = 0-17, IQR = 2-5 years).
Implications: Although health guideline formation and their use are also subject to prevailing practitioner attitudes and policy frameworks, this evaluation demonstrates how CTSA-supported research evidence is incorporated as one source of influence on evidence-based clinical guidelines. Understanding this translational process illuminates how continuing CTSA support of research may shape future research-informed clinical practices.


From Discovery to Policy Guidance: 20 Years of CTSA Research Shaping Evidence-Based Clinical Guidelines

Background/Objective 
The NIH General Clinical Research Centers (GCRC) program, established in 1960, provided centralized resources for patient-oriented research. In 2006, NIH consolidated GCRCs into the CTSA program, administered by NCATS beginning in 2011-2012. UCLA received its first CTSA award in 2011, renewed in 2016 and 2022, through the UCLA Clinical and Translational Science Institute (CTSI) partnership with Cedars-Sinai, Charles R. Drew University of Medicine and Science, and The Lundquist Institute at Harbor-UCLA. As research evolved into a complex, multi-site enterprise, UCLA transformed its centralized GCRC into a decentralized, service-rich Clinical and Translational Research Center (CTRC). This work describes the model's 20-year evolution and impact as CTSA marks its 20th anniversary in 2026.

Methods/Approach 
UCLA restructured its GCRC into a hub-and-rings CTRC model, extending research nursing, staff leadership development, and cross-site training across central, ambulatory, inpatient, and community sites, including gene and cell therapy nurse training. Key infrastructure included: (1) mixed billing using study-specific coverage analysis under Medicare Clinical Trial Policy to allocate costs between research/sponsors and clinical care/insurance; (2) “Without Walls” (WoW), launched in 2022, providing on-demand research nursing beyond the central unit to reduce participant burden and expand access; (3) FACT accreditation supporting cellular therapy facilities, training, and processing standards; and (4) the CIRM-funded UCLA Alpha Clinic, launched in 2015 and expanded in 2022 to improve access, outreach, and trial infrastructure for gene, cell, and regenerative medicine trials.

Results 
From 2018-2025, the UCLA CTRC served 8,322 unique patients across 103,251 research visits. From 2020-2026, it managed 196 mixed-billing trials and oversaw >750 trials, including registrational studies supporting 32 FDA-approved drugs. From 2020-2025, the CTRC supported 37 gene/cellular therapy trials, 107 Phase 1 trials, 778 industry-sponsored and 453 non-industry studies, and 87 mobile/contracted studies. WoW supported 64 projects at UCLA and 23 at Cedars-Sinai; a CTRC-certified facility animal completed 317 patient-support visits, the first such program in the CTSA network. Across four partner institutions, UCLA CTSI now supports >2,100 investigators, while California's CIRM Alpha Clinic network has expanded to nine sites delivering 28 cell and gene therapies. Highlight: Lifestyle Improvements in Men's Reproductive Health, supported at Lundquist.

Conclusions 
Sustained CTSA investment enabled UCLA to transform a centralized, lab-based GCRC into a decentralized, multi-service CTRC supporting complex translational research, including cell and gene therapy, mobile and community-based trials, and rigorous billing compliance. Future priorities include expanding decentralized/community trial capacity with digital technology community and stakeholder board input, scaling WoW across partner sites, growing CIRM funded community CARE Centers of Excellence, broadening FACT accreditation, and sustaining mixed-billing compliance as trial complexity increases.

From GCRC to CTRC: Two Decades of CTSA-Driven Transformation

Clinical and translational science increasingly depends on investigators who can lead interdisciplinary teams, build cross-institutional relationships, navigate complex research environments, and translate scientific expertise into collaborative action. Yet structured opportunities to develop leadership and team science competencies remain limited across academic health centers. To address this need, the Clinical and Translational Science Collaborative (CTSC) of Northern Ohio launched the Advanced Translational Leadership in Academic Science (ATLAS) Program in 2023 to strengthen leadership and team science capacity among investigators engaged in clinical and translational research. ATLAS integrates individualized leadership assessment and coaching, leadership and team science education, peer learning and reflective practice, interdisciplinary team-based projects, and application in real-world research settings.
A mixed-methods, cross-cohort evaluation examined ATLAS implementation, participant experiences, competency development, and sustained application across the 2024 and 2025 cohorts using pre/post competency assessments, session feedback, one-year follow-up, and alumni interviews. Participants demonstrated improvement across five competency domains, with notable gains in foundational leadership, team science and collaborative functioning, and research execution and translational operations. Impact extended beyond immediate competency development. Among 2024 participants completing the one-year follow-up (n=8), 87.5% initiated or joined a new cross-institutional collaboration, 75.0% developed a new research project, 62.5% published peer-reviewed work, and 37.5% received grant funding or became PI/Co-PI on a funded project. Qualitative findings identified self-awareness, reflection and psychological safety, relationships, and experiential learning as mechanisms supporting leadership development and application.
ATLAS illustrates how CTSA investment in translational workforce development can build the human and collaborative capacity needed for translational science. By developing leadership competencies, connecting investigators across disciplines and institutions, and catalyzing collaborations, research projects, publications, and grants, ATLAS strengthens teams positioned to move research toward practice. This pathway provides a foundation for longer-term Community and Public Health benefits within the Translational Science Benefits Model, with potential contributions to health care delivery through transdisciplinary collaboration and evidence-based practice and to public health practices through the application of scientific knowledge to improve community and population health. Ongoing evaluation will examine sustained partnerships, translational outcomes, and downstream TSBM benefits while informing adaptation and dissemination of transferable strategies across CTSA hubs.

From Leadership Development to Translational Impact: Building Collaborative Capacity Through ATLAS

Clinical research can stall at three interconnected bottlenecks: identifying eligible patients, assembling effective multidisciplinary teams, and launching multisite studies efficiently. Over the past two decades, the Harvard CTSA hub (Harvard Catalyst) has addressed these challenges by developing shared, scalable clinical research infrastructure that evolved from local innovations into widely adopted, national platforms. This poster traces that trajectory and highlights its impact within the Clinical & Medical domain of the Translational Science Benefits Model.
In 2009, Harvard Catalyst launched the first i2b2-SHRINE network, connecting affiliated academic medical centers through federated clinical data infrastructure. i2b2 integrates electronic health record, clinical trial, and genomic data, while SHRINE enables secure federated queries across institutions. The platforms support computed phenotypes, cohort discovery, study feasibility assessment, patient identification, and clinical trial design. i2b2 is now used at more than 200 hospitals worldwide. At Mass General Brigham alone, 834 research teams generated 4,472 clinical datasets in a single year; 43% reported that these data were critical to their studies. The SHRINE-powered EnACT network connects dozens of CTSA hubs and provides access to EHR data of more than 100 million individuals.
Harvard Catalyst developed Profiles Research Networking Software, a free, open-source platform that integrates institutional information with publications, grants, clinical trials, and other scholarly activities to facilitate expertise discovery and collaboration. At Harvard, our Profiles website, which includes 24,000 faculty and trainees, is viewed more than one million times annually. The Profiles software has also been adopted across multiple CTSA hubs, enabling investigators to identify collaborators, assemble multidisciplinary teams, and locate specialized research resources.
Harvard Catalyst also developed the IRB Reliance Agreement that evolved into SMART IRB. Initially established in 2009 among nine Harvard-affiliated institutions, the agreement expanded nationally and, by 2023, supported approximately 1,500 participating institutions, including all CTSA hubs. SMART IRB illustrates how locally developed governance infrastructure can reduce regulatory barriers and accelerate multisite research.
Collectively, these initiatives have generated measurable benefits across the clinical research lifecycle, enabling more precise cohort identification, stronger collaborative networks, and more efficient study activation. Harvard Catalyst is now extending this foundation through large-language-model-enabled phenotyping, cross-institutional data harmonization, investigator and dataset discovery, and other innovations. The resulting impact is a durable clinical research ecosystem that improves how studies are designed, launched, and conducted while supporting broader, more inclusive participation in research.

From Local Tools to National Platforms: Two Decades of Translational Science Impact at the Harvard CTSA

Background: Translating academic biomedical discoveries into patient-benefiting therapeutics remains a bottleneck in clinical and translational research. The Translational Therapeutics Accelerator (TRx), a CTSA-supported program at Columbia University Irving Medical Center, bridged this gap through 1. a commercialization boot camp covering market sizing, stakeholder analysis, regulatory and reimbursement strategies, and financing and business models; 2. industry mentorship and pitch coaching; and 3. early-stage pilot funding. This case study traces TRx's role in advancing Dr. Henry Colecraft’s therapeutic platform from academic discovery to a venture-backed company advancing toward clinical benefits.
 
Methods: We conducted a case study analysis using TRx program metrics, awardee milestones, and Translational Science Benefits Model (TSBM) domain mapping. 

Results: From 2016-2024, TRx invested $1.45 million of pilot funding across 31 therapeutics projects, generating $86 million in follow-on funding. Dr. Colecraft completed the boot camp and received two competitive pilot awards that carried his innovation to proof-of-concept of a next-generation therapeutic modality for protein stabilization (targeted deubiquitination therapeutics). Milestones included:
Launch of a company, Stablix,
Securing $63 million in Series A funding, and 
Licensing agreement with Vertex Pharmaceuticals that included upfront payment and royalty eligibility.1 

Conclusion: Structured commercialization support can accelerate the path from academic discovery to venture formation and industry partnership and potential clinical benefits. Stablix’s therapeutics aim to restore deficient protein levels in genetic disease, haploinsufficiency, and tumor suppressor loss—advancing a new therapeutic frontier and illustrating a scalable Translational Science Benefits Model-aligned approach to translating early-stage biomedical research into potential clinical impact and real-world value.

From Pilot Support to Clinical Translation: How TRx Catalyzed a Pathway To Patient Benefit; A Translational Science Benefits Model Analysis of CTSA Impact

Background: Prior to 2011 University of Minnesota (UMN) research staff operated in a decentralized environment, facing fragmented support, non-standardized onboarding, ad-hoc training, and the absence of a structured workforce framework. Most research staff were expected to “learn-as-you-go”, despite working in a complex and ever changing health research industry. To address these challenges, the Clinical and Translational Science Institute (CTSI) launched a long-term infrastructure initiative to build, scale, and professionalize the workforce. 
Methods: Over 15 years, CTSI implemented a multi-pronged workforce development model structured across three phases: Building the Foundation (2011–2016), Expanding Capacity (2017–2021), and Developing Leaders (2022–present). Key interventions included establishing a two-week onboarding program (Foundations for Research Professionals), launching standardized online training modules, implementing personalized training roadmaps, and mapping curricula to the Joint Task Force Clinical Trial Competency Framework (Sonstein et al., 2014). CTSI also partnered with UMN HR leadership as a key stakeholder to guide the development of dedicated Research Professional (RPs) job classifications, defining speciality lanes and progressive careers levels. To maintain relevance, program development was further informed by ongoing input from coordinators, Research Managers, surveys, and focus groups. 
Results: Since program inception, CTSI has achieved significant reach across the institution: Trained 837 RPs through Foundations and reached >11,800 cumulative attendees across 172 professional development seminars. Delivered online modules to 5,051 RPs, created over 1,000 Training Roadmaps, and completed 12 cohorts of regulatory training for 185 RPs. Contributed to establishing a dedicated HR Job Family, launched a Coordinator Engagement Group, piloted national mentoring curricula, and developed an employee experience survey that will be administered to ~2,900 UMN RPs.
Impact: Applying a TSBM, this approach yields economic benefits (reduced turnover and turnover-related study delays), clinical and public health benefits (safer trials, stronger data integrity, faster translation to practice), and community benefits (strong and ethically-minded relationships grounded in mutual trust, honesty, and transparency between RP and study participant). 
Conclusions: Consistent with classic markers of occupational professionalization (Wilensky, 1964), UMN's RPs workforce now reflects: dedicated job classifications, competency-based curricula anchored to a national framework, structured onboarding, and a Coordinator Engagement Group. Building on this foundation, TWD's next phase includes a Leadership Workshop Series and an employee experience survey which will extend the continuum toward sustained career advancement. This 15-year framework offers CTSA hubs a practical, adaptable model for professionalizing their own research workforce.

Growing a Profession: 15 Years of Transforming the Research Professional Workforce at the University of Minnesota

Introduction: The Northwestern University Clinical and Translational Sciences (NUCATS) Institute is collaborating with the Northwestern Medicine (NM) health system to advance quality improvement (QI) projects using replicable, rigorous implementation science (IS) methods. The IS2QI initiative will develop, deploy, and evaluate an IS toolkit, which maps pragmatic IS tools and frameworks onto each phase of NM’s QI workflow and can be implemented across the health system.  
Methods: A Strategic Initiative Advisory Board of 6 NM QI and 4 NUCATS IS experts collaboratively identify QI projects and gain health system buy in. The Implementation Research Logic Model is utilized to specify expected barriers and map the strategies needed to achieve the desired outcomes. Teams track and document use of specific implementation strategies and analyze the impact of new tools and process changes. Project benefits that align with the Translational Science Benefits Model (TSBM) domains were identified by project leads for assessment of potential and demonstrated benefits. 
Results: There are 2 ongoing IS2QI projects. Kishwaukee Hospital, a regional NM hospital, aims to decrease multi-visit patient (MVP) readmissions in the emergency department (ED) through a systemwide rollout of electronic health record flagging and data driven implementation strategies. Northwestern Memorial Hospital in Chicago aims to increase the timeliness and accuracy of radiology oncology simulation requests via site-specific standardized templates. The Kishwaukee Hospital IS2QI project identified 6 TSBM indicators in the domains of Clinical and Medical Benefits, Community and Public Health Benefits, and Economic Benefits. Interim data analysis identified quantifiable impact. ED readmission rates among MVPs decreased from 15% to 11.8% over a 12-month period and a new process for MVP outpatient appointment scheduling yielded 138 scheduled appointments with an 80% completion rate over 2 months. Analysis is ongoing for assessment of additional project components and long-term outcomes. The NM Radiology Oncology IS2QI project identified 5 TSBM indicators in the domains of Clinical and Medical Benefits, Community and Public Health Benefits, and Economic Benefits. Data collection is ongoing for future impact assessment.  
Discussion: The IS2QI initiative has been successful in identifying and launching projects across the NM health system. Actual and potential benefits of two IS2QI projects were mapped using the TSBM and spanned 3 domains and 8 indicators. Preliminary analyses of the project with interim data revealed measurable impact on health care quality and health care accessibility. 


Northwestern University ClinLiceaald ainngd tThraen wslaatyio tona bl eStcteiern ccaerse Institute Harnessing Implementation Science (IS) to increase the impact of Quality Improvement (QI)

Introduction: The Northwestern University Clinical and Translational Sciences (NUCATS) Institute is collaborating with the Northwestern Medicine (NM) health system to advance quality improvement (QI) projects using replicable, rigorous implementation science (IS) methods. The IS2QI initiative will develop, deploy, and evaluate an IS toolkit, which maps pragmatic IS tools and frameworks onto each phase of NM’s QI workflow and can be implemented across the health system.  

Methods: A Strategic Initiative Advisory Board of 6 NM QI and 4 NUCATS IS experts collaboratively identify QI projects and gain health system buy in. The Implementation Research Logic Model is utilized to specify expected barriers and map the strategies needed to achieve the desired outcomes. Teams track and document use of specific implementation strategies and analyze the impact of new tools and process changes. Project benefits that align with the Translational Science Benefits Model (TSBM) domains were identified by project leads for assessment of potential and demonstrated benefits. 

Results: There are 2 ongoing IS2QI projects. Kishwaukee Hospital, a regional NM hospital, aims to decrease multi-visit patient (MVP) readmissions in the emergency department (ED) through a systemwide rollout of electronic health record flagging and data driven implementation strategies. Northwestern Memorial Hospital in Chicago aims to increase the timeliness and accuracy of radiology oncology simulation requests via site-specific standardized templates. The Kishwaukee Hospital IS2QI project identified 6 TSBM indicators in the domains of Clinical and Medical Benefits, Community and Public Health Benefits, and Economic Benefits. Interim data analysis identified quantifiable impact. ED readmission rates among MVPs decreased from 15% to 11.8% over a 12-month period and a new process for MVP outpatient appointment scheduling yielded 138 scheduled appointments with an 80% completion rate over 2 months. Analysis is ongoing for assessment of additional project components and long-term outcomes. The NM Radiology Oncology IS2QI project identified 5 TSBM indicators in the domains of Clinical and Medical Benefits, Community and Public Health Benefits, and Economic Benefits. Data collection is ongoing for future impact assessment.  

Discussion: The IS2QI initiative has been successful in identifying and launching projects across the NM health system. Actual and potential benefits of two IS2QI projects were mapped using the TSBM and spanned 3 domains and 8 indicators. Preliminary analyses of the project with interim data revealed measurable impact on health care quality and health care accessibility. 

Harnessing Implementation Science (IS) to increase the impact of Quality Improvement (QI)

The National Center for Advancing Translational Science (NCATS) supports an NIH K12 award for career development in translational science. As part of the administration of this award, NCATS requires individual CTSA hubs to track K12 awardees long after they graduate from the program. At the University of Illinois Chicago’s (UIC) Center for Clinical and Translational Science (CCTS) efforts to track scholars after successful completion of the program have primarily included scholar self-report and direct scholar searches by K12 program and Evaluation & Tracking staff. 
Utilizing the self-report survey, former scholars can report their promotion and tenure, publications, and successful grant applications through a survey distributed by the K12 program staff. However, the survey requires substantial burden for former scholars to complete, and the response rate across all former scholars is 11.9%. The other option CCTS staff have used to report scholar success is through direct searches of scholar activity utilizing databases such as PubMed, NIH RePORTER, and Flight Tracker alongside personal profiles such as LinkedIn and internal university data. Using CCTS staff to conduct this work shifts the burden away from scholars but represents a substantial financial investment (approximately .42 FTE) on the part of K12 program and Evaluation & Tracking staff.
To reduce the financial investment required to adequately track scholars for reporting purposes and enhance our ability to quickly and accurately identify scholar impact, we worked with UIC’s AIHealth4All team to build a human-in-the-loop AI agent. The agent goes to work assembling a portfolio of evidence for each scholar including key scholar profiles, media mentions, career milestones, successful grant applications, and one sentence Translational Science Benefits Model (TSBM) impact summaries sourced from the evidence assembled by the agent. CCTS staff reviews each portfolio, including TSBM impact summaries, for accuracy and accepts, edits, or rejects the findings of the agent. Each CCTS staff reviewer accepted or edited 81.7% of the agent's findings and spent a median of 14 minutes per scholar, replacing an estimated 15 hours of manual assembly per scholar. Inter-rater agreement was moderate (Cohen's kappa 0.43 on the usable-versus-reject decision). The agent assembled evidence that covered all four TSBM domains.
By utilizing the AI agent, we were able to reduce the average investment of human hours into K12 scholar tracking by 98% per scholar, leading to increased efficiency and redirected staff effort. In the future, we plan to expand the use of the agent within CCTS and test the agent with other CTSAs to ensure the agent is able to work with other programs.


Improving operational efficiency through human-in-the-loop agentic AI for tracking K12 scholars

“The combined results of several people working together is often much more effective than could be that of an individual scientist working alone.” — John Bardeen, two-time Nobel Prize winner, American physicist and electrical engineer. 

Since its founding in 2008, the Indiana Clinical and Translational Sciences Institute (Indiana CTSI) has been built on the belief that collaborative, team-based science is one of the most effective ways to improve health. The Community Health Partnerships program has strengthened that vision over time by building an infrastructure rooted in community engagement. The mission is to improve the health of Indiana residents through community-university partnerships. 

By first listening to communities and then co-designing solutions with people who bring lived experience and local expertise, Indiana CTSI has been able to reach and serve all 92 counties across the state. Guided by the Community Advisory Board and a broad network of partners, Community Health Partnerships offers community-engaged research funding opportunities, community coalitions focused on chronic disease, human-centered design research teams, public engagement in clinical research, and partnerships with state health leaders. The network has expanded from 100 original partners to more than 800 today.  

Community Health Partnerships defines impact as the measurable and meaningful changes that result from community-university partnerships to improve health, strengthen communities, and translate research into action. Using the Translational Science Benefits Model from the Institute of Clinical & Translational Science at Washington University in St. Louis, this work demonstrates real-world Community and Public Health benefits in areas such as healthy built environments, public health practice, health education resources, disease prevention and reduction, resource access, and community power and partnerships. 

Indiana CTSI's Community Health Partnerships: A Shared Journey of Health Impact

We report an extensive Translational Science Benefits Model (TSBM) evaluation of the Colorado Clinical and Translational Sciences Institute (CCTSI) Pilot Grant Program, with a particular focus on the Clinical and Medical Contributions impact category. Since 2018, the CCTSI Pilot Grant Program has funded 242 pilot projects, providing a total of $7 million to address critical roadblocks in translational science. The goal of this study was to assess several measurable outcomes, including: (i) the timeline to clinical implementation of pilot project findings; (ii) career development outcomes for awardees; (iii) return on investment (ROI); and (iv) publication productivity.

Methods: We adapted the TSBM Impact Profile Template to evaluate the benefits and outcomes of CCTSI Pilot Projects. Input data were collected through an annual REDCap survey distributed to awardees from 2018 through 2024 and administered for up to five years following each award.

Results: As of 2026, 172 of 242 awardees (71%) had completed the survey. Among respondents, 40% reported that their funded projects achieved direct clinical impact and implementation within five years of funding, while 29% reported a community or public health impact. These findings are supported by the observation that more than 50% of pilot projects utilized human-subjects study designs. From an initial investment of $7 million, pilot awardees secured more than $131 million in follow-on funding, yielding an overall ROI of 19.26 across four pilot grant categories: Colorado Pilots (ROI = 17.63), Child and Maternal Health (ROI = 18.20), Translational Methods (ROI = 24.50), and Community Engagement (ROI = 19.43). Consistent with these findings, 50% of pilot projects obtained subsequent external funding, and 64% of awardees reported publishing their pilot study findings in peer-reviewed journals. Awardees identified five major translational science approaches represented in their pilot projects: development of statistical and research methodologies (62%); community-based participatory research (22%); patient recruitment and retention strategies (17%); drug and device development (11%); and informatics (11%).

Conclusions: The five-year follow-up period was sufficient to demonstrate both (i) meaningful clinical and community/public health impact and implementation, and (ii) substantial career advancement among pilot awardees. Comparatively less impact was observed in the economic and public policy domains. This may reflect both the nature of the funded pilot projects and the longer time horizons typically required for economic and policy impacts to emerge.

Investing in Translation: Impact of CTSA Pilot Funding Using the TSBM

LifeScale is a secure, cloud-based, multi-institutional trusted research enclave that integrates clinical and research data from The Ohio State University and Nationwide Children’s Hospital. By combining electronic health records with mother–baby linkage, and other population-level data within a governed, coded-limited environment, LifeScale reduces the data, governance, and analytic barriers that routinely slow translational research. This shared infrastructure supports a research-oriented learning health system in which research and clinical operations are connected through scalable, reusable infrastructure.
The acceleration is substantial. LifeScale reduces modeled time from research question to analytic result by 96%—from 304.6 to 12.6 days—saving approximately 292 days per project and an estimated 72.8 cumulative years across supported projects. Through the Translational Science Benefits Model, these gains demonstrate clear Economic Benefits through greater efficiency and cost effectiveness, Policy Benefits through reusable governance and cross-institutional data-sharing mechanisms, and Clinical and Medical Benefits through infrastructure that enables evidence to be generated and validated more rapidly.
LifeScale demonstrates how shared governance, multi-institutional data, and scalable analytics can function as translational science infrastructure. By reducing the time and friction between a research question and an analytic result, LifeScale enables investigators to move more rapidly from exploration and preliminary evidence through validation, collaboration, competitive funding, and translation—while preserving institutional control, responsible data stewardship, and patient confidentiality.

LifeScale Accelerates Translational Science: A Multi-institutional Trusted Research Enclave (TRE) that converts shared data  infrastructure into faster, reusable research answers 

Community engagement is central to translational science, yet its downstream impact is often difficult to demonstrate because evidence is dispersed across event evaluations and qualitative narratives rather than captured in impact-oriented measures. We retrospectively examined Penn State CTSI Community Engagement activities and artifacts from 2023–2025, including seven Community-Driven Research Days, 15 Community Engagement Studios, and three annual accomplishment narratives, and coded 41 narrative units using a combined framework of precursor implementation-science outcomes and Translational Science Benefits Model (TSBM) domains, applying published inclusion thresholds. The analysis showed that community engagement generated a substantial footprint beyond participation alone: 25 of 41 coded narratives (61.0%) contained evidence of implementation outcomes, 14 (34.1%) reflected capacity or output, and 2 (4.9%) met the threshold for a demonstrated TSBM benefit. These findings show how routinely collected community-engagement data can reveal where community voice and expertise enter the research process, shape research questions and partnerships, creating pathways toward downstream translational benefits. At the same time, the small proportion of narratives reaching demonstrated-benefit thresholds identifies an important measurement gap. This retrospective mapping provides both evidence of existing translational contribution and a practical roadmap for moving beyond documenting engagement, and signals a reproducible approach for capturing intermediate outcomes and eventual impacts.

Mapping Potential Translational Science Benefits Model Impacts and Translational Stages Across Community Engagement Events and Activities

Background
The University at Buffalo (UB) Clinical and Translational Science Institute (CTSI) evaluation framework incorporates a “Milestones” Longitudinal Case Studies Initiative to evaluate the impact of CTSI-facilitated activities, using a standardized approach adapted from the Translational Science Benefits Model and Retrospective Translational Case Studies Protocol. Narratives from cores (“Describe an interesting/important outcome from your core's services.”), are used to identify major achievements. This poster presents the initiative as applied to the CTSI Translational Pilot Studies Program 2017 project, “Randomized Controlled Trial of Exercise Treatment for Concussion.”
Historically, concussion management emphasized complete physical and cognitive rest until symptoms resolve. Many individuals fully recover in 2-4 weeks, but some experience persisting symptoms, highlighting the need for evidence-based approaches to facilitate recovery and prevent prolonged symptoms. UB researchers identified impaired autonomic and cerebral blood-flow regulation as characteristics of persisting post-concussion symptoms, providing a physiological rationale for controlled aerobic exercise in concussion rehabilitation.
Impact
This project has progressed over two decades from physiological discovery to clinical implementation. UB Interdisciplinary Development Research Fund supported development of the Buffalo Concussion Treadmill Test (BCTT) to determine an individual’s heart rate threshold at point of symptom exacerbation. Proof of concept studies demonstrated that sub-symptom aerobic exercise was safe and effective for individuals with persisting post-concussion symptoms. CTSI pilot funding enabled the first randomized controlled trial showing that sub-symptom threshold aerobic exercise prescribed within 10 days of sport-related concussion reduced recovery time from 17 to 13 days. Subsequent research showed a 48% reduction in risk of post-concussion symptoms persisting >30 days among adolescent athletes prescribed aerobic exercise treatment early after injury.
The Buffalo Concussion Protocol continues to be tested and adapted for different populations and settings, including the Buffalo Concussion Bike Test and the Buffalo March-in-Place Test for military personnel. Dr. Leddy served as a scientific member of the Concussion in Sport Group for the 5th and 6th International Conferences on Concussion in Sport, which led to a shift in international guidelines from prolonged rest toward individualized sub-symptom threshold aerobic exercise treatment. 
Conclusion
Healthcare providers have adopted the Buffalo Concussion Protocol to evaluate concussion patients, prescribe individualized aerobic exercise treatment, and guide return to sport decisions. This sustained research program helped shift clinical practice from prolonged rest toward active rehabilitation, contributing to shorter recovery times, fewer cases of persisting symptoms, and improved patient outcomes.

Milestones: CTSI Longitudinal Case Studies Initiative / Buffalo Concussion Protocol: Translating Physiological Discovery to Clinical Impact

Food allergy affects up to 8% of children and 10% of adults, and most affected children are allergic to more than one food. Prior to recent advances, management relied primarily on food avoidance and emergency treatment with epinephrine after accidental exposure. Oral immunotherapy offered an alternative approach, but it is burdensome and associated with adverse effects, underscoring the need for a safer and more effective treatment for patients with multiple food allergies. 

 The OUtMATCH trial was a multicenter, randomized, double-blind study designed to evaluate omalizumab for the treatment of multiple food allergy. Omalizumab, an anti-IgE monoclonal antibody originally approved for allergic asthma, was repurposed based on its biologic plausibility for food allergy. The study enrolled participants ages 1 to 55 years across 10 centers, with each participating center supported by its local CTSA. This collaborative 10-CTSA network enabled efficient execution of a complex multicenter trial. Participants were allergic to peanut and at least two additional foods from a set of six common allergens. The trial used a three-stage design: Stage 1 compared omalizumab with placebo over 16 weeks with oral food challenges at baseline and follow-up; Stage 2 evaluated omalizumab-facilitated multi-food oral immunotherapy over 52 weeks; and Stage 3 assessed the opportunity to introduce allergenic foods in dietary form after treatment. 

 Findings from OUtMATCH were published in the "New England Journal of Medicine" in February 2024 and contributed to FDA approval of omalizumab for food allergy, including use in patients as young as 1 year old. The study demonstrated improved food tolerance, higher treatment completion, and fewer serious adverse reactions compared with placebo and oral immunotherapy. As a result, OUtMATCH is viewed as a landmark example of successful drug repurposing and a major advance in the clinical management of multiple food allergy. These results also illustrate the role of a collaborative 10-CTSA network in generating practice-changing clinical and medical contributions. 

OUtMATCH: From Discovery to Practice-Changing Evidence

In recent years, T cell therapy has pioneered progress toward personalized cancer treatment and achieved substantial clinical success. This approach includes patient-specific T cell isolation, followed by ex vivo expansion/modification and subsequent reintroduction, altogether comprising a personalized immune response. However, rapid and modular ex vivo expansion to acquire robust, highly functional T cell populations—a key step—remain challenging, which in turn translate to high cost and low throughput. Meanwhile, groundbreaking progress has highlighted novel approaches towards overcoming these challenges, both from chemical biology and mechano-immunology perspectives. We combine these principles into a platform technology to advance the promises T cell therapy through precise spatiotemporal control of its therapeutics cue, mechanically and biochemically. This is achieved by uniting advances in polymer chemistry, protein engineering, and bioconjugation. 1) the hyperbranched bottlebrush polymer (BP) nanoarchitecture serves as the base material to enable modular design of multiplexed scaffolds. 2) Site-specific protein modification via insertion of azide-functionalized unnatural amino acids (UAA) affords precise and multivalent conjugates while rationally modulating biological functions. We developed 'click'-based bioconjugation methodologies to covalently incorporate relevant UAA-modified biologics onto BPs. BP-biomolecule conjugates (e.g., αCD3, αCD28, IL-2) were used to explore the exposure profiles interplay between different bioligands in the context of ex vivo T cell expansion. We also synthesized BP-based macroporous networks (MNs) with tunable mechanical features, thereby enabling mechanistic investigations of cell-material interactions.

Polymeric networks as scaffold for rationally programmable T cell expansion

Clinical and translational science programs are increasingly expected to demonstrate benefits beyond publications and subsequent grant funding, yet most evaluation occurs retrospectively and does not inform early portfolio management. We applied the Translational Science Benefits Model (TSBM) to prospectively characterize the anticipated health and societal benefits of 20 research projects supported by the Altman Clinical and Translational Research Institute (ACTRI). The portfolio included ACTRI Pilot, KL2, and K12 projects led by early career scientists and scholars across 2023-2026. Proposal titles, aims, translational barriers, planned outputs, implementation pathways, and expected benefits were abstracted and coded across the four TSBM domains: clinical, community, economic, and policy. All projects demonstrated anticipated clinical benefit, most demonstrated community benefit, and approximately half included plausible economic benefits through scalable platforms, reduced use of invasive procedures, commercialization, workflow efficiency, or improved resource allocation. Policy benefits were uncommon at the proposal stage and were most apparent in work addressing governance and standards for clinical artificial intelligence. Cross-cutting translational products included biomarkers, diagnostic assays, therapeutic candidates, devices, research platforms, and implementation pathways. The analysis also identified recurrent translational barriers, including limited human-relevant models, inaccessible measurement tools, lack of validated biomarkers, fragmented data and biospecimen workflows, and difficulty moving predictive models into real-time care. Prospective TSBM assessment provides a practical complement to conventional bibliometrics by making intended pathways to impact explicit at the time of award. Longitudinal follow-up can test whether anticipated benefits become realized benefits and can guide strategic investment, technical assistance, and evaluation across Clinical and Translational Science Award hubs.

Prospective Translational Impact Assessment of ACTRI-Supported Early-Career Research

School-Clinical Linkages Improve Pediatric Asthma Care: A Decade of CTSA Impact

This work describes the research program and career trajectory of Michelle Trivedi, MD MPH, a pediatric pulmonologist and asthma researcher. Dr. Trivedi was first funded by a CTSA Community Research Scholars Program award in 2017 to examine school staff perspectives on a school-supervised asthma therapy program. This grew into a NCATS-funded KL2 award that allowed Dr. Trivedi to develop and evaluate Asthma Link, a school-supervised asthma therapy intervention tailored for real-world settings, that ensures children receive their daily inhaler at school. Over 6 million children in the United States have asthma, causing billions of dollars in healthcare expenditures and over 14 million missed school days annually, with most childhood asthma morbidity attributable to medication non-adherence. This intervention fills an unmet need for the families, pediatric practices and schools that support children with poorly controlled asthma and has the potential to dramatically improve childhood asthma outcomes.

In 2026, Dr. Trivedi received a $3.86 million grant from the National Institutes of Health to lead a study aiming to answer questions about which children and communities benefit most from school-based health centers, and to determine if school-based health centers are providing effective healthcare and improving health outcomes for underserved communities and low-income families. School-based health centers (SBHCs) can address this unmet need by providing primary care at school. The proposed research will determine the effectiveness of SBHCs as a healthcare delivery system to improve pediatric asthma care.

The Shaping Professional Advancement through Research mentoring and Knowledge (SPARK) training program addresses a critical need for structured mentor training among graduate and postdoctoral researchers, the primary mentors who guide undergraduate and master’s trainees in day-to-day biomedical and translational research settings. The SPARK pilot program was developed through collaboration between the Montefiore Einstein Comprehensive Cancer Center’s Cancer Research Training and Education Coordination (CRTEC) office and the Harold and Muriel Block Institute for Clinical and Translational Research (ICTR) at Einstein and Montefiore. Over a seven-month period, this training program delivered a three-phase curriculum combining workshops, reflection, and structured evaluation. Twelve mentors completed the training, supporting 18 mentees directly during training and 31 additional students indirectly through program outreach. Quantitative and qualitative evaluation demonstrated marked improvements in mentors’ communication, goal setting, and ability to foster student learning and independence. All participants rated the program as relevant and would recommend it to others. Grounded in national best practices yet tailored to the Einstein and local Bronx academic ecosystem, SPARK provides a scalable, adaptable, modular evidence-informed model for strengthening near-peer mentorship quality, building evaluation capacity, and advancing inclusive, data-driven training environments within biomedical and translational research. 

Shaping Professional Advancement through Research Mentoring and Knowledge (SPARK)

The implementation of the NIH single IRB (sIRB) mandate in 2018 fundamentally transformed the multi-site research landscape in the U.S.—a shift furthered by similar provisions in the revised Common Rule (2020). To fulfill these requirements, institutions across the country (many with limited prior interaction) now routinely cede review or act as the IRB of record for collaborative research. These arrangements are made possible through reliance frameworks like the SMART IRB Agreement and related resources, which support a wide range of studies and have grown to nearly 1,500 participating institutions across North America, as of August 2026. To understand how research institutions locally operationalize sIRB review, SMART IRB solicited feedback through its network of participating institutions. The responses, summarized here, outline the practical realities of sIRB implementation and address (1) How does sIRB expansion affect research institutions’ systems and operations?, and (2) How does sIRB review function across diverse human research protection programs (HRPPs) in the U.S.?


Single IRB in Practice: Reliance Operations, Capacity, and Priorities

Page K, Willging C, Adsul P, Koch B, Summers P, Smith C, Huerta S, Tigges B

Objectives/Goals: Evidence-based interventions for hospitalized patients with opioid use disorder (OUD) rarely translate into sustained clinical services. We describe the translation of an inpatient addiction consult service (ACS) for this population from a multisite randomized trial into a permanent hospital service line at an urban hospital in the Southwest United States, followed by adaptation for rural acute care settings. We apply the Translational Science Benefits Model (TSBM) to characterize its impacts.
Methods/Study Population: The START trial (NCT05086796) randomized 325 hospitalized adults with OUD at three hospitals to a collaborative care-based inpatient addiction consult service (ACS; n=164) or standard of care (SOC; n=161); median age was 41 years. Outcomes were initiation of medication for OUD (MOUD) during hospitalization (electronic medical record [EHR]) and linkage to OUD treatment within 30 days of discharge (self-report). Trial findings informed the launch of “Coordinating Addiction Medicine with Inpatient and Outpatient Services” (CAMINOS), a permanent ACS expanded to also address unmet treatment needs related to alcohol use disorder (AUD) at the urban academic hospital. CAMINOS is now being evaluated using concurrent mixed methods guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, with data from key-informant interviews, quantitative surveys, and EHR-derived service metrics, integrated through joint displays.
Results: START participants were more likely than SOC participants to initiate MOUD during hospitalization (57.3% vs 26.7%; adjusted risk ratio [aRR] 2.10, 97.5%CI 1.51–2.91) and to link to OUD care after discharge (72.0% vs 48.1%; aRR 1.49, 97.5%CI 1.15–1.93). Since 2024, CAMINOS has served 2,083 patients (mean 97/month; mean length of stay 10.4 days); 47.7% initiated MOUD and 17.3% initiated treatment for alcohol use disorder. Readmission was 12.3%, post-discharge emergency department use 17.9%, and 15.2% left against medical advice; mixed methods analysis of CAMINOS implementation for OUD and AUD is underway. 
Discussion/Significance of Impact: Across TSBM domains, translation of the ACS model from trial to permanent service line yielded demonstrated clinical, community and public health, and potential economic and policy benefits. Demonstrated impact included expanded access to medications for OUD and AUD, improved post-discharge retention, and new partnerships with post-acute facilities that previously declined these patients. Ongoing adaptation in rural acute care hospitals, where access to these medications is disproportionately low, will extend these gains, with potential for new clinical guidelines and supportive policies, documented disease prevention and reduction, improved cost-effectiveness and cost savings, and decreased societal and financial costs associated with OUD and AUD.

START to System Change: Using the Translational Science Benefits Model to Trace Clinical and Translational Impact of an Inpatient Addiction Consult Service Model

Context: Disease burden, healthcare delivery, health outcomes, and life expectancy vary significantly across Virginia populations and communities, but comprehensive data for quantitative comparison are often limited. The Virginia All-Payer Claims Database (APCD) captures medical and pharmacy claims for 6 million Virginians, enabling comparisons of health measures across localities, payers, and population groups. Through community and stakeholder partnerships, we combine APCD data with state mortality, electronic health record, hospital, and socioecological data to create validated census tract-level measures for every Virginia community to generate actionable insights to improve health outcomes.
Methods: We ingest statewide medical, pharmacy, and enrollment claims from Virginia Health Information and integrated them with census and other public data into a single, normalized data warehouse. We build a library of standard measures combining national code sets (AHRQ, CMS) with definitions developed alongside subject matter experts. Using this library, we compute person/year metrics, which includes comorbidities, coverage, and utilization. We share these community-level metrics with partners statewide to support local research, care, and training efforts.
Results: Our big data-derived measures support a broad portfolio of partnerships across the Commonwealth. We create tailored claims datasets for VCU investigators conducting translational research. With the Virginia Opioid Abatement Authority, we identify communities with disproportionate opioid-related burden and inform interventions and resource targeting by funded cities and counties. For Virginia’s Rural Health Transformation grant, census tract scorecards identify needs, establish baselines, identify rural neighborhoods with greater needs, guide investments, and track outcomes. The data also support the Virginia Memory Project’s statewide dementia surveillance and registry, and the evaluation and strategic planning for the Virginia Mental Health Assistance Program. The infrastructure further powers the Wright Center’s NCATS RC2-funded Virginia Accountable Health Engagement and Action Dashboard (Va-AHEAD), which creates bright spot measures and conducts community asset mapping to identify communities doing better or worse than expected, uncover modifiable factors and community assets, and inform action across seven domains: primary care, obesity, colorectal cancer, opioid use, adverse childhood events, mental health, and cultural arts.
Conclusion: Claims, mortality, and socioecological data infrastructure provides a scalable, longitudinal foundation for generating actionable evidence across a broad range of health priorities. By enabling consistent measurement and community-level insight, it powers collaborations that guide resource allocation, strengthen health systems, and improve health outcomes for Virginians

Statewide Community-Level Claims and Socioecological Data Powering Translational Science for Action

The UC Davis Workforce Development (WFD) Program has blossomed into a robust CTS training program for students, fellows, staff, and faculty. Since the inception of the CTSC in 2006, the WFD program has grown to provide scientific and administrative support for CTSC TL1 and KL2 programs and 10 other research training and career development programs.The program’s graduates have matured into successful investigators and research program leaders both locally and nationally. The KL2 program boasts 73% of graduates with subsequent NIH research grants including 10 with R01s, while our TL1 Program graduates are academic faculty (45%), pursuing further academic training (18%), or employed in research-related (21%) or clinical roles (24%). In June 2024, the Mentored Clinical Research Training Program (MCRTP) for MD, DVM, and PhD early-stage faculty and postdoctoral fellows celebrated its 20th Annual Scholar Symposium with 140 scholar graduates since 2004. The award-winning Join the Team program for clinical research coordinators (CRC) has graduated 27 trainees recruited from our local community with 75% now employed as CRCs in health research settings. Additional WFD programming includes the recent additions of the Graduate Academic Unit Certificate in Translational Research; more than 30 instructor-led courses per academic year on Good Clinical Practice (GCP) and clinical research operations; the UC Davis T32 Council of PIs advocating for campus-wide T32 programs and best practices; and an expanded Mentoring Academy for Research Excellence (MARE) for mentor and mentee training. Expanding our reach to education and training for all clinical research staff professionals, the CTSC will develop foundational skills training in the first years of our first UM1 cycle. The UC Davis CTSC WFD Program directly addresses the shortage of professional research staff and clinical and translational scientists (CTS) needed for CTS teams of the future. Focusing on cross-disciplinary team science, boundary-crossing partnerships, and broadening the talent and experience of faculty and staff , the UC Davis CTSC WFD program has consistently helped research teams develop the skills, knowledge, and aptitudes necessary to coalesce the power of our comprehensive university and core collaborators to advance translational science and improve human health. 

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2026 Fall CTSA Program Annual Meeting

A Tool for Estimating Clinical Trial Operational Risk