The U.S. Food and Drug Administration announced a new program to observe clinical trials as they unfold, with the expressed goal of shortening drug development timelines by surfacing high-level signals about safety and efficacy while studies are underway.
FDA Chief AI Officer Jeremy Walsh told reporters that the agency plans to track aggregated indicators from ongoing clinical trials rather than pulling complete patient-level datasets. The objective is to detect relevant trends in near real time so regulators and sponsors can act more quickly without receiving raw, individual patient records.
Commissioner Marty Makary framed the move as part of an effort to strengthen the United States as a venue for drug research. He said the initiative responds in part to a trend of companies opting to start trials in other countries, citing China and Australia as examples where sponsors have been launching studies. The agency and the White House budget documents have indicated a desire to add options that can accelerate early-stage clinical research - an outcome that could be particularly helpful to smaller biotech firms.
The FDA published a request for information on Tuesday about using artificial intelligence to hasten early clinical research, calling the early phase a critical bottleneck in drug development. Makary reiterated the long timelines involved in bringing new medicines to market, stating that drug development typically requires 10 to 12 years and that roughly 45% of that period is consumed by paperwork and data entry.
Under the established process, sponsors collect results from study sites, conduct their own analyses, and then submit findings to the FDA. Walsh said that permitting regulators to view data as it is collected could enable companies to move candidate therapies into subsequent trial phases more rapidly.
The real-time monitoring approach is already being piloted in trials of two cancer drugs run by AstraZeneca and Amgen. Walsh said the effort was developed in collaboration with industry, and that a broader pilot will follow the initial tests. FDA leadership also emphasized that the program is not intended to replace standard communication or meetings between the agency and drug developers.
Contextual note: The announcement frames early clinical research as a chokepoint for development timelines and presents a monitoring pathway that preserves higher-level oversight while limiting transfer of granular patient-level data.