FDA launches effort to speed up clinical trials, using AI
statnews.com • • business
Key Points:
- The FDA announced initiatives to improve clinical trial efficiency by reviewing real-time data from ongoing trials by AstraZeneca and Amgen.
- AstraZeneca is conducting a Phase 2 trial for a combination therapy targeting aggressive lymphoma at MD Anderson Cancer Center and the University of Pennsylvania.
- Amgen is running a Phase 1b trial for a treatment targeting small cell lung carcinoma.
- Both trials utilize a real-time data platform developed by Paradigm Health to facilitate data monitoring.
- The FDA is seeking public input on a pilot program to collaborate with companies using AI to enhance safety monitoring, dose selection, safety signal identification, and patient recruitment in clinical trials.
