FDA deploys AI to monitor clinical trials in real time, cutting drug development by up to 40%

FDA to use AI to track clinical trials in real time

Why it matters: Agency leaders portrayed the move as a major step toward keeping U.S. biomedical research competitive against countries like China. Driving the news: The agency announced the launch of two "proof of concept" real-time trials to view safety and efficacy signals for an AstraZeneca drug used to treat lymphoma and an Amgen drug for small cell lung carcinoma. * It also solicited public comments for a broader pilot program for real-time trials that could launch this summer. It will be aligned with an AI risk management framework developed by the National Institute of Standards and Technology. * The process could circumvent what officials call a bottleneck in drug development, in which results from trial sites are reported to manufacturers, who then analyze and submit data to the FDA. What they're saying: "Today is a milestone day for us to challenge the assumption that it takes 10 to 12 years for a new drug to come to market," FDA commissioner Marty Makary told reporters. * On average, 45% of the time between a Phase 1 clinical trial and submission of an application to the FDA is "dead time" spent on paperwork and other administrative tasks, he said. * The new initiative seeks to cut down on that time to move the process faster "without cutting any corners on safety," he said. FDA chief AI officer Jeremy Walsh told reporters "there is opportunity to shave off" as much as "20, 30, 40% of an overall clinical trial time."

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

By Deanna Neff HealthDay ReporterWEDNESDAY, April 29, 2026 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon mean more options for patients who need life-saving medications. The agency announced Tuesday that it has completed the first tests of a system that allows FDA scientists to see safety and effectiveness data from patients as it is collected. This shift aims to turn the traditional, stop-and-go process of drug testing and reporting into a continuous stream of live data. Drug development now happens in distinct stages. When one phase ends, there is often a long pause while researchers compile data to report to the FDA and wait for approval to start the next step. By using artificial intelligence and modern data science, the FDA hopes to eliminate these gaps entirely. "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," FDA Commissioner Dr. Marty Makary said in a news release. By seeing safety signals in real time, the FDA aims to identify potential risks or breakthrough successes immediately, rather than waiting for a final report months later. The agency highlighted two trials already using this technology. AstraZeneca is testing a treatment for mantle cell lymphoma, while Amgen is conducting a trial for small cell lung cancer. In both cases, the drug developers are sharing live signals with the FDA, showing that the technology appears ready for the mainstream. The technology they're using is embeded into workflows at hospitals through companies like Paradigm Health. Its AI-powered platform was used for AstraZeneca's multi-site lymphoma trial, capturing data directly from a patient's electronic health record and other sources, and reported to the FDA in real time. Jeremy Walsh, the FDA's chief AI officer, said the human cost of waiting for data is too high. "Real-time trials have been talked about for years," he said. "We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem." The FDA has released a Request for Information to help design a larger pilot program launching this summer. The agency is looking for feedback from scientists and drug makers through May 29, to ensure the system is both efficient and secure. More information Learn more about clinical research at ClinicalTrials.gov. SOURCES: U.S. Food and Drug Administration, news release, April 28, 2026; Paradigm Health, news release, April 28, 2026