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-11192578 · Data updated 2026-11-12
This study is working to make sure new medical technologies and treatments are safe and effective by bringing together experts to improve how they are tested and approved, using smart tools like machine learning.
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) | $454,318 |
| NIH project number | 3U01FD007857-02S4 |
| Project ID | NIH-11192578 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients who are interested in new therapies and technologies that are being evaluated for safety and efficacy would be ideal candidates to benefit from this research.
✕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 utilize advanced methodologies such as machine learning and statistical approaches to enhance regulatory decision-making and ensure that new products are safe and effective for public use.
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 focused on regulatory science have shown promise in improving the evaluation processes for medical products, indicating that this approach has potential for success.
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.