U.S. Food and Drug Administration (FDA) shared a post on LinkedIn:
“Today, the FDA announced two major milestones in implementing real-time clinical trials:
- Successful Proofs-of-Concept: FDA unveiled proof-of-concept trials with AstraZeneca and Amgen that report endpoints and data signals in real time.
- Pilot Program: The agency released a request for information (RFI) for a broader pilot program launching this summer.
This initiative is designed to:
- Enhance patient safety monitoring
- Accelerate regulatory decisions
- Reduce drug development timelines
- Build toward continuous trials across all phases.”
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