As part of the FDA’s real-time trial review effort, the agency says the pilot will rely on a real-time data platform built by Paradigm Health for the AstraZeneca and Amgen studies. The FDA’s briefing frames the workflow around enabling reviewers to assess safety signals and other decision-support data as information arrives, rather than waiting for periodic submissions. AstraZeneca’s trial will be conducted across sites including MD Anderson and the University of Pennsylvania, while Amgen’s real-time study is a Phase 1b trial in small cell lung carcinoma. The FDA is also seeking public input on whether and how to expand the AI-enhanced safety monitoring concept beyond the initial pilot. The operational focus is likely to influence how sponsors structure data feeds, governance, and model outputs during ongoing trials.