Protecting Federal Research Funding Through ClinicalTrials.gov Support

Context

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.

CTSA Contribution

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.

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.

Outcome / Impact

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.

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.

Once the required updates were submitted and accepted, NIH cleared the RPPR, and the Notice of Award was issued without interruption.

“My sincere thanks to everyone for working hard to help me resolve all the regulatory/reporting issues.” 
— Oyebimpe Adesina, M.D., M.S., Associate Professor of Clinical Internal Medicine, UC Davis School of Medicine

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.

Why It Matters

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.

Timeline of Impact

• Ongoing: ClinicalTrials.gov oversight, consultation, and coordination support is an ongoing CTSC service for the institutional research portfolio.
• 2025: This ClinicalTrials.gov support function monitored 704 non-cancer studies, identified 69 issues, and identified four studies requiring registration as of September 2025.
• 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.
• 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.