FDA Gears Up Real-Time Trials Fueled by AI to Accelerate Drug Development
The FDA will speed drug development by reviewing real-time trial data from AstraZeneca and Amgen and is seeking public input on a pilot using AI to improve safety monitoring, dosing, and recruitment. The efforts include AZ’s Phase 2 lymphoma trial at MD Anderson and UPenn, and Amgen’s Phase 1b small cell lung cancer study, all supported by Paradigm Health’s real-time data platform.