The FDA began piloting real-time clinical trials (RTCTs) to accelerate early-phase decision-making by having sponsors report endpoint data to the agency as results emerge. The agency described pilot studies with AstraZeneca and Amgen, including a validated framework for real-time signal sharing. The FDA said it met with both sponsors prior to start to establish reporting criteria, and it subsequently received and validated signals for AstraZeneca’s trial via Paradigm Health. FDA Commissioner Marty Makary characterized the program as a way to reduce multi-year lag times that can delay regulatory decisions. For biotech developers, the operational change could be material: RTCTs aim to shift part of the signal review workflow earlier in development, potentially affecting trial design communications, monitoring processes, and sponsor-agency alignment around safety endpoints.