The FDA announced a pilot approach to review clinical trial data in real time, starting with datasets from AstraZeneca and Amgen. The agency said it will also solicit feedback on a potential program for companies using AI to support safety monitoring, dose selection, safety signal detection, and patient recruitment. A central element is the real-time data platform Paradigm Health is building for the pilot trials, according to the FDA. The Phase 2 AstraZeneca study of an aggressive lymphoma regimen will run at MD Anderson and the University of Pennsylvania, while Amgen’s Phase 1b small-cell lung cancer trial will use the same real-time reporting concept. If adopted broadly, the initiative could shorten the information latency between trial events and regulator review, reshaping how sponsors design data flows and monitoring systems for pivotal studies.