The FDA announced a pilot program to access and review clinical trial data in real time as it flows from sponsors, marking a step toward more continuous oversight rather than post-hoc data packages. The agency said it will begin with review of real-time data from trials run by AstraZeneca and Amgen. Under the initiative, FDA plans to collaborate with companies using AI-enabled systems to support safety monitoring, dose selection, identification of safety signals, and patient recruitment. AstraZeneca’s Phase 2 lymphoma trial will run at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania using a real-time data platform built by Paradigm Health; Amgen’s Phase 1b small cell lung cancer trial is also part of the pilot. The FDA also invited public input on the potential AI-related component, with the goal of evaluating whether faster access to trial information can improve review efficiency and decision-making quality.