The U.S. FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot program to June 29, responding to requests from sponsors and CROs seeking additional time. The agency said it aims to gather input on how AI can support real-time endpoint and safety monitoring as trials progress. The pilot is intended to let sponsors report endpoint data as it is generated, improving efficiency in early-phase development and supporting go/no-go decisions. FDA said it is exploring how data-science advances could improve safety signal detection, dose selection, and monitoring workflows. The extension provides more time for the pharma ecosystem to shape regulatory expectations around how AI systems interface with continuous trial operations—an area of growing urgency as the FDA pursues faster, more data-dense development models.