The U.S. Food and Drug Administration recently announced two major steps aimed at accelerating the adoption of real-time clinical trials, a shift officials say could modernize drug development and reduce delays in bringing treatments to patients.

The agency revealed the successful launch of two proof-of-concept trials that transmit endpoints and safety signals directly to regulators as they occur, a news release said. It also issued a Request for Information seeking public input on a broader pilot program set to begin this summer.

Early-stage clinical trials have long been a bottleneck in drug development, marked by limited patient populations, uncertainty and slow data reporting. Traditionally, trial data flows from research sites to sponsors, who analyze results before submitting them to the FDA, a process that can take years.

Advances in artificial intelligence and data science now allow sponsors and research sites to share information in real time, potentially improving safety oversight and speeding decision-making.

“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,” said FDA Commissioner Marty Makary, M.D., M.P.H., in the release. “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.”

The FDA said AstraZeneca and Amgen have initiated the first proof-of-concept real-time trials under the effort. AstraZeneca’s Phase 2 multi-site trial, known as TRAVERSE, focuses on patients with treatment-naïve mantle cell lymphoma and includes participation from The University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial, STREAM-SCLC, targeting patients with limited-stage small cell lung carcinoma, with final site selection still underway.

For both studies, the FDA worked with sponsors to establish criteria for reporting data signals in real time. The agency said it has already received and validated signals from AstraZeneca’s trial through Paradigm Health, demonstrating the technical feasibility of real-time data sharing.

“Real-time trials have been talked about for years. We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem,” said Chief AI Officer Jeremy Walsh. “We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment.”

Officials say the initiative is a step toward “continuous” clinical trials, an approach that could eliminate the pauses that typically occur between phases of development. Currently, most clinical research is conducted in separate phases, each governed by its own protocol. The transition from one phase to the next often introduces delays that slow overall progress.

By allowing regulators to monitor trials continuously, real-time data sharing could reduce or eliminate those gaps, speeding the path from early research to approved therapies.

The FDA is now seeking feedback on how to design and evaluate a larger pilot program. The agency will accept comments on the Request for Information through May 29. Officials plan to release final selection criteria in July and complete pilot selections in August.