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-11192577 · Data updated 2026-11-12
This study is working to make sure that new medical treatments and technologies are tested and monitored better, so patients like you can get safe and effective options more quickly.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Univ of North Carolina Chapel Hill NIH-funded |
| Lab location | 1 site (Chapel Hill, United States) |
| Project start | September 1, 2023 |
| Project end | August 31, 2028 |
| Funding year | 2024 |
| Award (this year) | $450,533 |
| NIH project number | 3U01FD007857-02S3 |
| Project ID | NIH-11192577 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for participation or benefit from this research include patients who are awaiting new therapies or medical devices that are currently under regulatory review.
✕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 among universities and regulatory bodies to enhance methodologies for pre-market evaluation and post-marketing surveillance. Patients can benefit from more effective and timely access to new treatments as the research seeks to close existing gaps in regulatory science. The approach includes leveraging advanced statistical methods, machine learning, and other innovative techniques to ensure that new products are safe and effective.
Why it matters
Potential benefit: If successful, this research could lead to faster and more reliable access to innovative medical treatments 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
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.