The FDA moved toward faster early-phase drug development by piloting real-time clinical trials (RTCTs), in which sponsors report signals and endpoints as data are generated. The agency says it validated a technical framework through a pilot with AstraZeneca, enabled via Paradigm Health, and received and assessed real-time signals in parallel with trial progress. FDA leaders framed RTCTs as a way to cut lag time between data readouts and agency visibility that can otherwise delay regulatory decisions. The agency also released plans for additional pilot selection criteria and requested public input ahead of final selection later this year. A separate FDA governance item also surfaced, with the agency narrowing its search for a new head of CBER to three to four final candidates. While not a clinical outcome, leadership timing can influence how quickly regulatory process changes are rolled out across biologics oversight.
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