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FDA Launches Real-Time Clinical Trial Pilot Using AI, Targeting 20–40% Reduction in Trial Duration

2026-04-29 19:08

The FDA announced a pilot program using AI and cloud computing to receive continuous clinical trial data streams rather than batch submissions at study endpoints, with AstraZeneca (a Phase 2 lymphoma trial at MD Anderson and UPenn) and Amgen (a Phase 1b lung cancer trial) as the first participants using the Paradigm Health platform. FDA Chief AI Officer Jeremy Walsh said the approach could eliminate 20–40% of overall clinical trial time by enabling real-time safety signal detection and adaptive dose decisions. The agency also released a Request for Information for a broader expanded program, with final selection criteria expected in July 2026, per STAT News.

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