The FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot assessment, moving the deadline to June 29. The agency said the extension responded to requests from sponsors and CROs seeking additional time to submit feedback. The RTCT pilot is aimed at letting trial teams report endpoint data to the agency as data are generated, using technologies that may include AI. The FDA highlighted potential benefits ranging from improved trial efficiency and safety monitoring to dose-selection decisions and earlier go/no-go signals. The initiative references pilot concepts involving AstraZeneca and Amgen, and it follows earlier FDA calls for input on how AI can be used to accelerate early-phase drug research. If implemented, it could alter how sponsors structure data flows, governance, and interactions with regulators throughout early clinical development. For the industry, the longer comment window provides more time to address practical issues like data quality, validation, and how “real-time” reporting interfaces with existing regulatory expectations.