The U.S. FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot. The agency pushed feedback timing to June 29, responding to requests from sponsors and CROs seeking more time to evaluate how AI could be used to report endpoint data as trials progress. The RTCT effort is aimed at accelerating clinical decision-making and improving safety monitoring, including faster go/no-go assessments. The pilot is tied to a broader FDA push toward more continuous visibility into trial endpoints rather than waiting for later data packages. For biopharma, the extension is a near-term window to shape guidance that could influence trial design, data submission workflows, and how adaptive intelligence is operationalized across early-phase development.
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