The FDA extended the comment period for its real-time clinical trial (RTCT) pilot covering how AI can be used to report endpoint data during early-phase studies. The agency pushed the deadline to June 29 in a post in the Federal Register after requests from sponsors and CROs for additional time. In May, the FDA had called for feedback on plans that could allow sponsors to use AI and data technologies to report endpoint information as trials progress. The regulator said the objective is to improve trial efficiency, safety monitoring, dose selection, and support earlier go/no-go decisions. The RTCT pilot discussion has also been linked to the broader policy question of whether regulators can accelerate decisions while maintaining data quality and robustness. For biotech developers, the extended window offers another chance to shape expectations around data standards, model governance, and how real-time signals should be interpreted during regulatory review.