The FDA moved to speed early drug development by piloting real-time clinical trials (RTCTs), where sponsors report safety and endpoint signals to the agency as data are generated. The agency described two RTCT pilots with AstraZeneca and Amgen and said it has already received and validated signals through Paradigm Health for AstraZeneca’s study. FDA said RTCT reporting criteria are established upfront with sponsors and focuses on signal visibility rather than waiting for end-of-study datasets. The agency also launched a request for information on a broader pilot program, seeking public comment through the end of May and targeting final selection criteria in July. The FDA framed RTCTs as a way to reduce the lag between when signals emerge and when regulators can assess them—potentially shortening timelines for early-phase decisions. FDA Commissioner Marty Makary called the lag “unnecessarily” delaying regulatory decisions, while Chief AI Officer Jeremy Walsh said the approach is feasible and potentially transformative.