The FDA launched a pilot effort to collect and review clinical trial data in real time, starting with oncology studies from AstraZeneca and Amgen. The agency said reviewers will access information as it flows in, aiming to reduce delays between trial conduct and safety signal evaluation. The pilot is expected to use a real-time data platform built by Paradigm Health for the selected studies. AstraZeneca’s Phase 2 lymphoma study will run at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania, while Amgen’s Phase 1b trial in small cell lung carcinoma is also included. The FDA is also asking for public input on a potential broader AI-enabled safety monitoring and dose-selection program. The move signals a regulatory shift toward more continuous oversight of trial data streams, particularly in oncology where timelines are tightly linked to patient access. For sponsors, the initiative raises operational questions around data infrastructure, audit readiness, and how quickly evolving protocols and safety information can be reflected for regulatory review.