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<p>This article highlighted a CTSI-supported program that gives students early exposure to authentic research experiences, demonstrating how hands-on participation can spark interest in research careers and strengthen the future translational science workforce. The story showcased CTSI's commitment to training the next generation of investigators while increasing awareness of educational pathways that connect students to clinical and translational research opportunities.</p>

Workforce development

Undergraduate

Careers

University of Utah

<p>Raised awareness of CTSI training programs and showed how early research experiences build the future translational science workforce.</p>

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Early Exposure to Authentic Research Strengthens the Translational Science Pipeline

Education and Training

Translational Science

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<p>Impact shows how CTSA-supported research and programs move beyond discovery to create meaningful changes in public health, healthcare, and communities.</p>

What is Impact?

<p>It leads to more effective treatments, better patient care, improved healthcare policies, better-prepared medical workforce, and guidance for productive medical research.</p>

Why it Matters

<p>We demonstrate impact through stories and data. Together, they help bring the real-world value of translational science to life.</p>

How to Show It

<p>Clinical research teams must meet complex federal reporting requirements to maintain accurate public records and protect research continuity. Support from the UC Davis CTSC helped strengthen oversight, consultation, and coordination of ClinicalTrials.gov across the institutional research portfolio. In one case, NIH identified a mismatch between information reported in a Research Performance Progress Report (RPPR) and the corresponding ClinicalTrials.gov record. As part of what appeared to be a new NIH review process, funding actions could not proceed until both systems were aligned. Tiffany T. Norris, M.S., ClinicalTrials.gov Management Specialist with the UC Davis CTSC, helped the study team navigate reporting requirements, reconcile information across systems, and complete the review process. NIH cleared the RPPR and issued the Notice of Award without interruption. Across the portfolio, this ClinicalTrials.gov support function monitored 704 non-cancer studies and identified 69 issues.</p>

University of California at Davis

<h4>Context</h4><p>ClinicalTrials.gov records are a public-facing source of information about clinical studies and must be accurate, complete, and maintained over time. For investigators and institutions, these records are also tied to federal reporting expectations, NIH Research Performance Progress Reports, and compliance reviews. When ClinicalTrials.gov records do not align with study documents or NIH reporting materials, investigators can face delays, administrative burden, compliance risk, and possible interruption to federal research funding.</p><h4>CTSA Contribution</h4><p>The UC Davis Clinical and Translational Science Center (CTSC) provided ClinicalTrials.gov expertise, consultation, troubleshooting, and coordination for investigators and study teams. Tiffany T. Norris, M.S., ClinicalTrials.gov Management Specialist with the UC Davis CTSC, supported the non-cancer ClinicalTrials.gov portfolio by providing guidance on Applicable Clinical Trial criteria, registration, record updates, maintenance, results reporting, validation errors, and Protocol Registration and Results System (PRS) reviewer responses.</p><p>ClinicalTrials.gov support also coordinated with institutional partners to improve systems and workflows, including ClinicalTrials.gov-specific updates to the Institutional Review Board (IRB) Initial Review Application, a ClinicalTrials.gov checklist in OnCore to improve National Clinical Trials (NCT) number capture, and support for the NCT Number Re-Attestation Project.</p><h4>Outcome / Impact</h4><p>A high-priority example involved Oyebimpe Adesina, M.D., M.S., and the Sickle Cell Disease Bone Pain Study. During NIH review of the study's Research Performance Progress Report (RPPR), a mismatch was identified between information reported in NIH systems and the corresponding ClinicalTrials.gov record. NIH confirmed that it was cross-checking RPPR information against ClinicalTrials.gov records and that funding actions could not proceed until discrepancies between the systems were resolved.</p><p>As part of what appeared to be a relatively new NIH review process, Dr. Adesina and Clinical Research Coordinator Leyla Teos worked directly with Norris to understand the requirements and determine the appropriate path forward. Through consultation meetings, ongoing coordination, and ClinicalTrials.gov regulatory support, the team reviewed the discrepancy, reconciled information across systems, and successfully navigated the ClinicalTrials.gov review process.</p><p>Once the required updates were submitted and accepted, NIH cleared the RPPR, and the Notice of Award was issued without interruption.</p><blockquote><p><i>“My sincere thanks to everyone for working hard to help me resolve all the regulatory/reporting issues.”&nbsp;</i><br>— Oyebimpe Adesina, M.D., M.S., Associate Professor of Clinical Internal Medicine, UC Davis School of Medicine</p></blockquote><p>The same ClinicalTrials.gov support function also strengthened institutional oversight. In 2025, this ClinicalTrials.gov support function monitored 704 non-cancer studies, identified 69 issues, and identified four studies requiring registration as of September 2025. The team also helped resolve two major NIH non-compliance threats, including the Sickle Cell Disease Bone Pain Study and a telemedicine wound care study that had received a notice of non-compliance and a 30-day deadline to avoid loss of NIH funding. Through consultation, record review, correction, and coordination, ClinicalTrials.gov support helped protect research continuity and improve institutional readiness for federal registration and reporting expectations.</p><h4>Why It Matters</h4><p>This story shows how CTSA-supported regulatory infrastructure can protect federally funded research, reduce administrative barriers for investigators, and strengthen the reliability of public clinical trial information. The impact extends beyond a single study because the same support model can be applied across disease areas, departments, and funding mechanisms. By helping investigators navigate ClinicalTrials.gov requirements and evolving federal reporting expectations, CTSC support helps protect research continuity, strengthen compliance infrastructure, and reinforce public trust in clinical and translational research.</p><h4>Timeline of Impact</h4><ul><li>Ongoing: ClinicalTrials.gov oversight, consultation, and coordination support is an ongoing CTSC service for the institutional research portfolio.</li><li>2025: This ClinicalTrials.gov support function monitored 704 non-cancer studies, identified 69 issues, and identified four studies requiring registration as of September 2025.</li><li>During NIH RPPR review: NIH identified a mismatch between information reported in NIH systems and the corresponding ClinicalTrials.gov record, and funding actions could not proceed until discrepancies were resolved.</li><li>After required updates were submitted and accepted: NIH cleared the RPPR, and the Notice of Award was issued without interruption. The study team experienced the impact through continued award processing, protected research continuity, and reduced reporting barriers.&nbsp;</li></ul>

<p>ClinicalTrials.gov support resolved RPPR discrepancies, protected NIH funding, and strengthened regulatory reporting workflows.</p>

UC Davis Clinical and Translational Science Center (CTSC) logo. Image Credit: UC Davis CTSC.

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UC Davis Clinical and Translational Science Center logo.

UC Davis Clinical and Translational Science Center

Protecting Federal Research Funding Through ClinicalTrials.gov Support

<p>A new collaboration between the Medical University of South Carolina (MUSC) and the University of Florida (UF) is taking a cutting-edge approach to transforming healthcare research and outcomes across the Southeast. The Southeastern Health AI Consortium supports interdisciplinary teams addressing major regional health challenges by leveraging artificial intelligence (AI), large clinical datasets, and combined institutional expertise. Backed by $2.5 million in funding, the projects span a broad array of focus areas that affect South Carolinians, Floridians, and the broader Southeast region, including mental health, maternal health, stroke, brain health, and advanced therapies.</p>

Medical University of South Carolina

University of Florida

<p>This unique partnership between two CTSAs is addressing pressing health care problems with ethical AI use.</p>

The Southeastern Health AI Consortium, led by MUSC and the University of Florida, is using AI to accelerate discovery, improve care and transform health across the Southeast. Image courtesy of Canva

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The Southeastern Health AI Consortium, led by MUSC and the University of Florida, is using AI to accelerate discovery, improve care, and transform health across the Southeast.

From Algorithms to Outcomes: AI is Rewriting Healthcare in the Southeast

<p>SLiCE (Screening Live Cancer Explants) is a breakthrough University of North Carolina at Chapel Hill developed technology that tests patient tumor samples on living tissue, creating a realistic environment for studying brain cancer. Developed by Drs. Andrew Satterlee, Shawn Hingtgen, and Albert Baldwin, and strengthened by NC TraCS translational science training, SLiCE enables tumors to behave as they do in the body and allows researchers to test multiple drugs within days. This platform has become a UNC Core Facility and is already driving major collaborations to accelerate preclinical drug development, including work with Nobel laureate Aziz Sancar, showing that the repurposed agent EdU outperforms standard chemotherapy in several glioblastoma samples. SLiCE is now paving the way for functional precision medicine, offering faster, more accurate, and personalized treatment insights for patients.</p>

Duke University

University of North Carolina at Chapel Hill

<p>Brain cancer, particularly the aggressive form known as glioblastoma, remains one of the most challenging diseases to treat. Fewer than 10% of adults diagnosed survive beyond five years, and treatment options have changed little in the past two decades. One major reason for this slow progress is the difficulty of studying glioblastoma in a way that truly reflects what happens inside the human brain. Once removed from the body, tumor cells often die, and those that survive typically behave very differently when grown on standard plastic lab dishes. Without a realistic, reliable model of the disease, scientists have struggled to test new drugs or predict which treatments might help patients.</p><p>At the University of North Carolina at Chapel Hill, a breakthrough technology is changing that. It’s called SLiCE, short for Screening Live Cancer Explants, and it was developed by UNC-Chapel Hill researchers Andrew Satterlee, Ph.D., Shawn Hingtgen, Ph.D., and Albert Baldwin, Ph.D. SLiCE engrafts tumors on substrates of living tissue to keep patient tumor samples growing in an environment that feels natural. This creates a tiny, living microcosm of the brain right on a lab bench, giving scientists an entirely new way to study cancer.</p><p>What makes this approach especially meaningful is how it combines creativity, personal motivation, and the power of translational science training. With support from the North Carolina Translational and Clinical Sciences (NC TraCS) Institute, UNC’s NCATS Clinical and Translational Science Awards (CTSA) hub, Drs. Satterlee and Hingtgen learned how to turn a research idea into a real-world medical platform. Today, SLiCE is a UNC core facility being used in major research collaborations, including one with Nobel laureate Aziz Sancar, M.D., Ph.D., to explore promising new anti-cancer agents.</p><h4>A Personal Motivation</h4><p>Satterlee’s journey toward developing the SLiCE platform began when he was diagnosed with a rare brain cancer in 2007, when he was 20 years old. As a college student, Satterlee and his family had to navigate a therapeutic odyssey that included brain surgery, chemotherapy, and radiation therapy. Satterlee’s family sought advice from several top doctors who did not agree on what treatments he should receive, and it was eventually up to Satterlee himself to decide how to proceed. At the time, Satterlee thought, “There must be a better way to do this.” He is building that tool today.</p><h4>SLiCE Fills a Gap in Cancer Research</h4><p>Satterlee’s case isn’t unique; studying brain cancer has always been a challenge. Even though these tumors grow rapidly inside patients, they often fail to survive when moved into lab conditions. On plastic lab dishes, tumor cells lose their structure and behavior. In animal models, experiments can take months and the cancer still may not behave in the same way it does in a real person. For this reason, we don’t know for sure if treatments that work in the lab dish will really work in a person.</p><p>SLiCE offers a “best of both worlds” solution. By placing a patient’s tumor directly onto the SLiCE platform, the tumor continues to thrive in a realistic setting, surrounded by living brain cells. This environment helps preserve the tumor’s shape, growth patterns, and behavior. Researchers can then apply different drugs directly to the tumor to determine which treatments are most effective at killing the cancer cells. Within just four days, SLiCE can generate meaningful results with the speed of a cell culture assay and the fidelity of an animal model. This combination of speed and complexity makes SLiCE especially promising for both preclinical drug development and precision medicine, where treatments are chosen based on how a specific patient’s tumor responds.</p><p>With SLiCE, scientists can test multiple drugs at once on real tumor tissue, observe how those tumors respond in real time, and generate faster, more accurate predictions about which treatments are most likely to work. &nbsp;Because different drugs might work better for one tumor than another tumor, this approach may allow SLiCE to “customize” treatment to each patient. This powerful approach reflects exactly the kind of translational science the CTSA program is designed to support, turning laboratory insights into tools that can directly impact patient care.</p><h4>Translational Training That Sparked Innovation</h4><p>Dr. Andrew Satterlee’s and Dr. Shawn Hingtgen’s training as NC TraCS Scholars equipped them with the translational mindset needed to rethink how cancer models are built. Early in his work with Hingtgen, Satterlee noticed that some tumor cells were not migratory in a dish, but inside the body, they behaved completely differently, rapidly invading throughout the brain. “Why would we design a therapy using a totally artificial model?” Satterlee recalls. Guided by the translational principles they learned through the TL1 (Satterlee) and K12 (Satterlee and Hingtgen) programs, the two scientists and their teams developed SLiCE technology. On SLiCE, the cells grew much like they do in an animal, revealing a far more realistic model for studying disease. This ability to question past teachings, adopt clinically relevant approaches, and bridge basic science with patient?focused innovation led to a multi-institutional U01 grant from the NIH’s National Center for Advancing Translational Science (NCATS) and has helped their larger team transform SLiCE into a platform now poised for broad use across many neurological diseases including Alzheimer’s disease and stroke.</p><h4>A Breakthrough: SLiCE Meets Aziz Sancar’s Discovery</h4><p>One of the most exciting uses of SLiCE came when Nobel laureate Aziz Sancar and his team discovered something surprising about a lab chemical called <a href="https://pubmed.ncbi.nlm.nih.gov/41474743/" target="_blank" rel="noopener noreferrer">EdU</a>. EdU is normally used to track cell division, but <a href="https://pubmed.ncbi.nlm.nih.gov/40130554/" target="_blank" rel="noopener noreferrer">Sancar’s lab</a> found that EdU can cross the difficult-to-penetrate blood-brain barrier, and cause death of cancer cells.</p><p>This discovery hinted that EdU might be able to attack glioblastoma in ways that standard chemotherapy cannot.</p><p>Sancar partnered with the SLiCE team to test this hypothesis by treating patient glioblastoma tumors with EdU on SLiCE. A series of experiments, led by Humeyra Kaanoglu, a PhD candidate in Sancar's lab, and Adebimpe Adefolaju, a Ph.D. candidate in the Hingtgen Lab, showed that EdU repeatedly outperformed temozolomide, the only FDA-approved chemotherapy for glioblastoma. Furthermore, combination therapy studies on SLiCE revealed that EdU may synergize with several other FDA-approved chemotherapies to further increase tumor kill. These studies led to two high-impact publications in less than one year.</p><p>This early success suggests that EdU, or drugs like it, could become powerful new tools in treating brain cancer.</p><h4>Toward a Future of Personalized Treatment</h4><p>SLiCE is helping shift the field toward functional precision medicine, where doctors choose treatments based on how a patient’s own tumor responds, rather than relying only on tumor imaging or genomic information about the tumor. Imagine a future in which a patient is diagnosed with glioblastoma, surgeons remove a small part of the tumor, the sample is placed onto the SLiCE platform, where several drugs are tested, and within days doctors know which therapy is most likely to work. This kind of personalized approach could help patients avoid ineffective treatments, reduce harmful side effects, and improve their chances of survival.</p><h4>A Translational Success Story</h4><p>SLiCE is much more than a laboratory technique; it is a model for how translational science should work.</p><ul><li>A young scientist receives CTSA training.</li><li>The scientist develops a new technology to solve a real medical problem.</li><li>That technology becomes a core resource used by many research teams.</li><li>An inventive (and in this case, Nobel Prize-winning) collaborator uses the platform to test a promising new drug.</li><li>And together, they move closer to improved treatments for one of the deadliest cancers.</li></ul><p>For patients and families facing brain cancer, SLiCE represents something rare: genuine hope.</p><p>With the support and collaboration of NC TraCS, the CTSA program, and NCATS, innovators like Dr. Andrew Satterlee are building the tools needed to bring scientific discoveries out of the lab and into the lives of the people who need them most.</p><p>&nbsp;</p><blockquote><p><i>“We've got to think about things differently,” Satterlee says. “And that's what TraCS and NCATS—and what we—want to do.”</i></p></blockquote>

<p>UNC’s SLiCE tests brain tumor samples on living tissue, enabling multi-drug screening in days and accelerating precision treatment insights.</p>

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