The FDA extended the public comment period for its AI-powered real-time clinical trial (RTCT) pilot, pushing feedback due to June 29. The agency said it granted the additional time after requests from sponsors and CROs seeking more opportunity to respond to its plan for using AI to report endpoint data as trials proceed. The pilot is intended to improve trial efficiency, support safety monitoring, and enable faster go/no-go decisions in early development. The FDA previously cited examples of the approach in work by AstraZeneca and Amgen. Analysts framed the extension as a window for the industry to shape how the agency will evaluate AI use in regulatory decision-making—an issue with implications for trial operations and documentation requirements across drug development.
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