The FDA launched a pilot program for real-time clinical trials (RTCTs) intended to accelerate early-phase development by letting sponsors report safety signals and endpoint data as trials progress. The agency described RTCT pilots with AstraZeneca and Amgen, including technical validation of signal sharing for an AstraZeneca study via Paradigm Health. In its announcement, FDA said it met with both sponsors before initiation to define reporting criteria for signals, aiming to reduce the lag time that can delay regulatory decisions. FDA Commissioner Marty Makary and FDA Chief AI Officer Jeremy Walsh framed RTCTs as a modernized way for regulators to see safety information sooner. The agency also opened a request for information for an additional pilot program, seeking industry input through the end of May. FDA plans to disseminate final selection criteria in July and complete pilot selections in August, indicating a near-term rollout path for broader participation.