Leo Sher, M.D.

The U.S. Food and Drug Administration (FDA) on April 28, 2026, announced two major steps to advance real-time clinical trials (RTCT). First, it launched two proof-of-concept trials that report endpoints and data signals to the agency in real time. Second, it issued a Request for Information on a proposed pilot RTCT program planned for the summer. Early-phase clinical trials are often slow and inefficient, with delayed data reporting and analysis. Advances in AI and data science now enable real-time monitoring, improving safety oversight and decision-making speed. FDA leadership emphasized that reducing delays in data transmission could accelerate regulatory decisions and drug development timelines. The agency confirmed that AstraZeneca and Amgen have initiated RTCTs, demonstrating the feasibility of real-time signal sharing. Building on these efforts, the FDA aims to expand RTCT through a broader pilot program with defined evaluation metrics. Ultimately, real-time trials could enable continuous clinical development by minimizing delays between phases and speeding patient access to new therapies.

Reference

1. US Food and Drug Administration, news release, April 28, 2026. URL: https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials#xd_co_f=Y2ExYmE2ZWEtZWU0MS00OTQxLTk1NjQtNjE1OTk1ZTUxNTZh~