On April 28, 2026, the U.S. Food and Drug Administration (“FDA”) announced additional steps in its ongoing initiative to advance real-time clinical trial approaches, including proof-of-concept studies and a request for information supporting a planned pilot program focused on real-time or near-real-time clinical trial data capture and review (the “Announcement”).
FDA Commissioner Marty Makary, M.D., M.P.H., stated:
“For 60 years, we’ve been conducting clinical trials in the same way, where key data signals can take years to reach the FDA. The lag time can delay regulatory decisions unnecessarily and slow down the drug development timeline. We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses. This will help us accelerate promising therapies and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.”
According to the FDA, these efforts are designed to explore whether more timely access to trial data during clinical studies may support and improve earlier identification of safety signals and more efficient oversight of ongoing trials, particularly in early-phase development settings.
The Announcement reflects the FDA’s interest in evaluating modernization approaches that could improve how clinical trial data are collected, transmitted and assessed within existing regulatory frameworks, and includes early pilot activities.
The FDA has not yet proposed binding requirements or formal rulemaking associated with real-time clinical trial implementation; rather, the initiative is described as exploratory and pilot-based in nature, with active proof-of-concept studies. Additional stakeholder input and evaluation are needed prior to broader adoption.
Practical Takeaways
The Announcement is relevant to ongoing discussions around clinical trial data infrastructure, including data integrity controls, system validation and the governance of technologies that may enable more frequent or continuous data flow from trial sites to sponsors and regulators, as well as auditability and regulatory defensibility of near-real-time data streams in clinical trials.
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