The U.S. Food and Drug Administration (FDA) is taking a major step toward faster drug development by introducing real-time clinical trials, a move that could expand access to life-saving treatments.

The agency announced it has successfully tested a system that allows its scientists to monitor patient safety and treatment effectiveness as data is generated, rather than waiting for final reports at the end of each trial phase.

Traditionally, clinical trials follow a step-by-step process, often delayed by long gaps between phases as researchers compile and submit data for review. The FDA now aims to replace this “stop-and-go” model with a continuous flow of live information using artificial intelligence and modern data tools.

“For 60 years, we've been conducting clinical trials in the same way… the lag time can delay regulatory decisions unnecessarily,” said FDA Commissioner Dr. Marty Makary.

By accessing real-time data, regulators hope to quickly detect safety concerns or identify promising results, potentially accelerating decisions and reducing risks for patients.

Two early trials are already using this approach. AstraZeneca is testing a treatment for mantle cell lymphoma, while Amgen is running a study on small cell lung cancer. In both cases, live data is being shared directly with the FDA.

The system relies on AI-powered platforms embedded in hospital workflows, such as those developed by Paradigm Health, which collect data from electronic health records and transmit it instantly to regulators.

FDA Chief AI Officer Jeremy Walsh said the innovation could transform the clinical trial landscape. “We demonstrated that it is not only possible, but also potentially transformative,” he noted, highlighting the urgency of reducing delays that can cost lives.

The FDA is now seeking public and industry feedback to refine the system, with plans to launch a larger pilot program later this year.