The FDA launched a pilot framework for real-time clinical trials, allowing sponsors to report endpoint and safety signals as data are generated rather than waiting for study completion. The agency said it has already validated the technical approach through an AstraZeneca pilot using Paradigm Health and plans to broaden input through a request for information. FDA expects real-time trials to compress timelines for early-phase decision-making. The pilots establish reporting criteria with sponsors before initiation, with FDA aiming to disseminate final selection criteria in July and complete pilot selections in August. Industry impact is immediate for biotech sponsors building Phase 1-2 programs, where lag between data generation and regulatory visibility can slow protocol iterations and investment decisions. FDA framed the move as part of a broader push to modernize trial conduct with faster signal access.