The FDA launched pilot efforts for real-time clinical trials (RTCTs) designed to compress early-phase timelines by sharing endpoint and safety signals as they are generated. The agency said it validated technical reporting frameworks through AstraZeneca’s and Amgen’s pilot studies before opening a broader request for information. Under RTCTs, sponsors report relevant signals to the agency during the trial rather than waiting for end-of-study packages, aiming to reduce lag time in regulatory decision-making. The FDA plans to solicit input through late May, publish final selection criteria in July, and complete pilot selections in August. FDA Commissioner Marty Makary described the program as a shift away from “key data signals” taking years to reach the agency. The FDA also tied the initiative to AI-enabled trial optimization and signal handling through its “real-time signal sharing” approach. For biotech developers, RTCTs could change how Phase 1–2 programs are structured, monitored, and communicated—especially for sponsors seeking earlier regulatory alignment on safety and efficacy signals.