The FDA extended the public comment period for its AI-powered real-time clinical trial (RTCT) pilot, giving sponsors and CROs more time to respond to proposed approaches for using AI in endpoint reporting and monitoring. The agency pushed the deadline to June 29 after receiving requests for additional time. The pilot would allow endpoint data to be reported in real time as trials progress using AI-related technologies, aiming to improve trial efficiency and safety signal detection and to support faster go/no-go decisions in early studies. The update comes on top of earlier FDA interest, including references to pilot studies involving AstraZeneca and Amgen, and it sets the stage for how AI could influence early development decisions in the U.S.
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