FDA is launching real-time monitoring of drug trials, with AstraZeneca and Amgen as first test cases

The agency says 45% of drug development time is currently "dead time" — real-time data access could cut months or years from the process

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The FDA announced this week that it will begin monitoring clinical trial data in real time, allowing agency scientists to view safety signals and trial endpoints as they occur rather than waiting for sponsors to analyze and submit data through the traditional reporting process.

Two companies have signed on as early participants: AstraZeneca $AZN -1.67%, whose Phase 2 TRAVERSE trial — enrolling treatment-naïve mantle cell lymphoma patients at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania — is already underway, and Amgen $AMGN -0.90%, which is in later stages of site preparation for its own study. Data signals from the AstraZeneca trial have already been transmitted to and confirmed by the agency, flowing through a platform operated by software company Paradigm Health. Amgen is running a Phase 1b trial called STREAM-SCLC in patients with limited-stage small cell lung carcinoma, with final site selection still in process.

"Amgen is committed to advancing approaches that help bring innovative medicines to patients more efficiently. By evolving how evidence is generated, we see opportunities to reduce the burden on patients and clinical sites without compromising established ethical and regulatory standards," the company said in a statement.

Speaking to reporters, FDA Commissioner Marty Makary, M.D., described a development pipeline where the stretch from an initial Phase 1 study to a final approval submission can span 10 to 12 years — and where nearly half that window passes with no trial actually running. "For 60 years, we've been conducting clinical trials in the same way, where key data signals can take years to reach the FDA," Makary said in a statement.

In the traditional model, results collected at study sites are handed off to the sponsoring company, which processes and interprets them before anything reaches regulators. Real-time access would let agency scientists watch signals emerge as a study runs, a shift that FDA Chief AI Officer Jeremy Walsh told reporters could trim Bloomberg amounts to "months, if not years" from the overall development clock.

When asked about privacy, Walsh made it clear that the agency does not seek individual patient records, according to Fierce Biotech. He said the focus is on whether overall data signals are enough to support regulatory decisions. Officials also emphasized that regular discussions and meetings with drug developers will still be part of the process.

The agency also published a request for information this week seeking public input on the design of a broader pilot program, including evaluation metrics and success criteria. The FDA said it intends to publish final selection criteria in July and complete pilot selections in August. Comments on the request are due by May 29, 2026.

Looking ahead, the agency wants to replace the stop-and-start pattern of traditional drug development with a continuous process, which it calls continuous trials. Right now, programs often pause between phases while companies prepare paperwork, and the FDA sees this as a major bottleneck for moving early-stage therapies forward.

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