The FDA launched a pilot program to collect and review clinical trial data in real time, aiming to give reviewers earlier visibility into safety signals and other critical information as studies run. The agency said it will start by reviewing live data feeds from trials conducted by AstraZeneca and Amgen. Under the plan, FDA also asked for public input on a potential pilot to work with companies using AI for tasks such as safety monitoring, medication dose selection, and patient recruitment. AstraZeneca’s Phase 2 lymphoma combination trial will run at MD Anderson Cancer Center and the University of Pennsylvania using a Paradigm Health platform. Amgen’s parallel effort involves a Phase 1b trial in small cell lung cancer, also built on a real-time data platform from Paradigm Health. The initiative reflects a shift toward continuous regulatory oversight rather than post-hoc dossier review. Separate reporting echoed the same FDA initiative, underscoring that “real-time” access by scientific reviewers is central to the pilot’s design and that the two companies already aligned with FDA to test the workflow.