Accelerating the evaluation and monitoring of new medical products
Research Triangle Center of Excellence in Regulatory Science and Innovation
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 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 ID | NIH-11175913 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Ideal candidates for benefiting from this research include patients who require access to new therapies and medical technologies that are currently under evaluation.
Not a fit: Patients who are not seeking new treatments or who are not affected by FDA-regulated products may not receive direct benefits from this research.
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 performed: 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
Chapel Hill, United States
- 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 below.