The US FDA extended the comment period for its real-time clinical trial (RTCT) pilot focused on AI-assisted reporting of endpoints during early-stage studies. In a Federal Register notice, the agency moved the deadline to June 29 after sponsor and CRO requests for additional time. FDA’s stated aim is to use AI and data science to improve trial efficiency, enhance safety monitoring, support dose selection, and inform early go/no-go decisions. The agency cited pilot work including AstraZeneca and Amgen as examples of how data might be reported as trials progress. The longer window gives the pharma and CRO ecosystem time to shape practical guidance on AI deployment, data quality expectations, and regulatory evaluation criteria—an issue likely to affect trial design workflows in 2026 and beyond.