The FDA said it is piloting real-time clinical trials (RTCTs), a model in which sponsors report endpoint data as it is generated to speed assessment of safety signals and early efficacy. In updates, the agency described two RTCT pilots—one with AstraZeneca and one with Amgen—and said it has validated the technical feasibility of a real-time signal-sharing framework, including signals received for AstraZeneca’s study through Paradigm Health. FDA Commissioner Marty Makary framed the change as a response to lag time in traditional trial reporting, which can delay regulatory decisions and slow development timelines. The FDA also said it will accept public input for a proposed additional pilot program through the end of May, with final selection criteria planned for July and pilot selection completion in August.