This poster describes a collaboration between AIM-AHEAD and NCATS to develop a national AI/ML workforce using real-world clinical data in N3C. The program trained 153 early-career clinicians and data scientists through coursework, mentorship, and hands-on projects. Reported outcomes include increased AI/ML knowledge and confidence, scientific presentations, publications, grants, promotions, and the development of a scalable workforce model.

Advancing National AI/ML Skills in Translational Informatics: the AIM-AHEAD & NCATS Health Data Science Training Program

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2026 Fall CTSA Program&nbsp;Annual Meeting

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Clinical and Medical Contributions

Community and Public Health

Economic Benefits

Policy

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

03.01_NCATS Welcome_KurillaM.pdf

03.02_NCATS Session_HartshornC.pdf

Discover the N3C:  Unlocking Real-World Data  to Accelerate Translational  Impact

Real-world Evidence Innovation Challenge

03.03_Keynote_MikhailK.pdf

03.04_AIinPractice.pdf

Chatbot  for Informed Consent:  Overcoming Barriers

Researcher Expertise Matching

Building the Future with Digital  Twins Using Machine Learning  and Generative AI

From Clinical Questions to Real-World Evidence:  Building an AI Agent for EHR-Based Clinical and  Translational Research

Building the SHIRE: A Closed Ecosystem for EHR data Analysis

03.05_WorkforceDev.pdf

Growing a Profession

Building the Behavioral Research  Workforce: The PRIME Approach

Advancing the Research Workforce: Career Pathways,  Professional Growth, and Research Staff Perspectives

03.06_Poster Session Impact Statements.pdf

03.07_RecruitmentandRetention.pdf

Building Recruitment Strategy from Disease Area to  Study Level

Recruitment & Retention: Design the Trial Around the Participant

Participant Recruitment & Retention

Panel Participants

04.01_Day2Welcome.pdf

04.03_InnovationsinClinicalTrials.pdf

Using MOST to Optimize Tobacco Dependence Treatment in the Emergency Department

A SMART Approach to Treating Tobacco Use Disorder in Persons with HIV: SMARTTT “1.0”

Embedded Pragmatic Trial Designs: Rapidly Generating Evidence and Improving Care

Engaging with the Trial Innovation Network

04.04_AcceleratingRuralResearch.pdf

Implementing a Training-of Trainers Opioid Overdose Education  and Naloxone Distribution Model in  Rural Community Pharmacies

Accelerating Rural Research to Improve Health: A Multi-Component Strategy

CTSA Consortium of Rural States

Research with Rural Communities that Increases Capacity

Rural Connections to Research

04.05_Closing and Top Takeaways.pdf

02.01_ECPlenarySession.pdf

Session Opening

Fireside Chat and Q&A with Dr. Rajiv Kumar 

Panel Discussion: Building Trust in an AI Enabled Research Environment

Session Goal Card

Closing Statement

02.03_IntegrationAcrossTheLifespan

Welcome & Opening Remarks

A Toolkit for Investigators and People with Disability Experience (PWDE)

Pediatric Clinical Trials Working Group

Rare Disease and an Evolving Regulatory Environment

Repairing DNA Damage to Reverse Vascular Aging in Progeria

Table Discussions / Networking

 Report-outs & Full-group Discussion

Closing Remarks & Adjourn

02.04.WorkforceDevelopmentEC.pdf

Welcome, Introductions

Microcredentials and Digital Badging

Communicating Your Expertise

Structured Networking

Working Group Presentations

Adjourn

02.05_HubAdministrators.pdf

Welcome & Housekeeping

Artificial Intelligence in Hub Administration

Networking Break

Facilitated Table Discussions

Evaluation Impact: Measuring and Demonstrating Success

Wrap-Up: Meeting Evaluation

Award Ceremony and Closing

02.06_BIDS.pdf

Welcome & Introductions

Preparing Every Researcher for the Data-Intensive Future: Session Charge

Panel 1: Models for Sustainable Training

Moderated Discussion and Audience Q&A

Panel 2: Competencies for Emerging Quantitative Roles

Key Takeaways, Next Steps, and Closing Remarks

02.07_Collaborations&Engagement.pdf

Opening Remarks

Meet & Mingle Bingo

Table-Based Topic Discussions: Think Tank

Think Tank Report-Outs

Lean In/ Lean Away Group Poll & Closing Remarks 

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 

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

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.


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2026 Fall CTSA Program Annual Meeting

Advancing National AI/ML Skills in Translational Informatics: the AIM-AHEAD & NCATS Health Data Science Training Program