NIH-funded research U01 cooperative agreement

Accelerating the evaluation and monitoring of new medical products

Official title: Research Triangle Center of Excellence in Regulatory Science and Innovation

Funded at Univ of North Carolina Chapel Hill · NIH-11175913 · Data updated 2026-11-12

This study is working to make sure new medical technologies and treatments are safe and effective for everyone by bringing together experts to create better ways to test and monitor these products before and after they hit the market.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniv of North Carolina Chapel Hill
NIH-funded
Lab location1 site (Chapel Hill, United States)
Project startSeptember 1, 2023
Project endAugust 31, 2028
Funding year2024
Award (this year)$668,333
NIH project number3U01FD007857-02S1
Project IDNIH-11175913 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates for benefiting from this research include patients who require access to new therapies and medical technologies that are currently under evaluation.

Less likely to help

Patients who are not seeking new treatments or who are not affected by FDA-regulated products may not receive direct benefits from this research.

What this research studies

This research focuses on improving the evaluation and monitoring processes for innovative medical technologies and therapeutics regulated by the FDA. By establishing the Research Triangle Center of Excellence in Regulatory Science and Innovation, the project aims to create a collaborative environment that brings together experts from various fields, including academia and industry. The center will develop new methodologies and tools, such as machine learning and statistical approaches, to enhance both pre-market evaluations and post-marketing surveillance of medical products. This initiative seeks to address existing gaps in regulatory science to ensure that new products can be safely and effectively utilized by the public.

Why it matters

Potential benefit: If successful, this research could lead to faster and more reliable access to innovative medical products for patients.

How similar studies have gone: Other research initiatives in regulatory science have shown promise in improving evaluation processes, indicating that this approach could yield significant advancements.

Where this research is happening

  • Univ of North Carolina Chapel Hill
    Chapel Hill, United States
    Active

Researchers

  • Principal investigator: Watkins, Paul B — Univ of North Carolina Chapel Hill
  • Study coordinator: Watkins, Paul B

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.