The FDA has begun piloting real-time clinical trials (RTCTs) designed to speed early-phase decision-making by allowing sponsors to report safety and endpoint signals as data are generated. The agency disclosed two RTCT pilot efforts—one with AstraZeneca and another with Amgen—along with a validated signal-sharing framework. FDA said it met with both sponsors before initiation to agree on reporting criteria for signals and that it subsequently validated AstraZeneca’s RTCT signals through Paradigm Health. FDA Commissioner Marty Makary said the lag between traditional trial data collection and regulator visibility can unnecessarily delay decisions. The FDA also opened a request for information on a proposed RTCT pilot program, seeking public input through the end of May, with final selection criteria expected in July and pilot selections targeted for August.