Safety of switching between brand and generic drug-and-device products
The Safety of Switching Between Complex Branded and Generic Drugs: Developing a Semi-Automated Sequential Surveillance System Using Tree-Based Scan Statistics
['FUNDING_U01'] · BRIGHAM AND WOMEN'S HOSPITAL · NIH-11178354
This project checks whether switching between brand-name and generic medicines that include delivery devices is linked to safety problems by scanning large healthcare records.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | BRIGHAM AND WOMEN'S HOSPITAL (nih funded) |
| Locations | 1 site (BOSTON, UNITED STATES) |
| Trial ID | NIH-11178354 on ClinicalTrials.gov |
What this research studies
If you use medicines that come with a delivery device (like inhalers or auto-injectors), this project aims to make it safer when people switch between brand-name and generic versions. The team will build a semi-automated system that scans large, long-term U.S. health records to look for unexpected medical problems after switches. It uses tree-based scan statistics to search across many diagnoses and events and flags patterns that merit closer review. Findings would help regulators and clinicians detect safety signals faster than waiting for voluntary reports.
Who could benefit from this research
Good fit: People who use complex drug-device combination products (for example, inhalers, auto-injectors, or other medicines sold with a delivery device), especially those who have recently switched or may switch between brand-name and generic versions.
Not a fit: People who do not use drug-device combination products or who never switch between brand and generic versions are unlikely to directly benefit from this work.
Why it matters
Potential benefit: If successful, the system could help detect safety problems sooner, increase confidence in generic drug-device products, and support safer prescribing and switching decisions.
How similar studies have performed: Tree-based scan statistics and large healthcare-database safety methods have previously found safety signals for drugs and vaccines, though applying a semi-automated sequential system specifically to drug-device switching is relatively new.
Where this research is happening
BOSTON, UNITED STATES
- BRIGHAM AND WOMEN'S HOSPITAL — BOSTON, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: WANG, SHIRLEY — BRIGHAM AND WOMEN'S HOSPITAL
- Study coordinator: WANG, SHIRLEY
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.