Investigating the safety of switching between branded and generic drug-device combinations.
Official title: The Safety of Switching Between Complex Branded and Generic Drugs: Developing a Semi-Automated Sequential Surveillance System Using Tree-Based Scan Statistics
Funded at Brigham and Women's Hospital · NIH-11062850 · Data updated 2026-11-12
This study is looking at how safe it is to switch between expensive brand-name and generic drug-device combinations, and it aims to create a system that helps track any side effects or effectiveness of these medications to make sure patients can trust the generic options.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Brigham and Women's Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project start | September 1, 2024 |
| Project end | August 31, 2027 |
| Funding year | 2024 |
| Award (this year) | $298,422 |
| NIH project number | 1U01FD008316-01 |
| Project ID | NIH-11062850 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research include patients who use or are considering using complex drug-device combinations, particularly those who may switch between branded and generic versions.
✕Less likely to help
Patients who are not using or do not plan to use drug-device combinations may not receive any benefit from this research.
What this research studies
This research focuses on the safety of switching between complex branded and generic drug-device combinations, which are often expensive medications. It aims to develop a semi-automated surveillance system that utilizes real-world evidence to monitor adverse effects and effectiveness of these products after they have been approved by the FDA. By analyzing large healthcare databases, the study seeks to provide more reliable data on the safety of these medications, helping to inform regulatory decisions and improve patient confidence in generic options.
Why it matters
Potential benefit: If successful, this research could enhance the safety monitoring of generic drug-device combinations, leading to better patient outcomes and increased access to affordable medications.
How similar studies have gone: Other research has shown success in using real-world evidence to monitor drug safety, indicating that this approach has potential for meaningful impact.
Where this research is happening
-
Brigham and Women's Hospital
Boston, United States Active
Researchers
- Principal investigator: Feldman, William Brand — Brigham and Women's Hospital
- Study coordinator: Feldman, William Brand
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.