FDA Says First ‘Real-Time’ Clinical Trial Is Underway

The FDA announced the launch of the first “real-time” clinical trial, with a second soon following, that will enable agency reviewers to see certain data signals immediately.

Both are cancer trials and considered proof-of-concept. The agency also released a request for information for a larger pilot program set to start this summer.

“This is not a theoretical,” FDA Commissioner Marty Makary, MD, MPH, said during a press briefing on Tuesday. “Today, up and running, is a real-time clinical trial, live today.”

Makary explained that FDA reviewers will be able to “see safety signals and clinical endpoints in the cloud in real time as a clinical trial is happening.”

“When a patient in a clinical trial develops a fever, or is hospitalized, or a tumor shrinks, and a radiologist reads the new tumor size, the FDA regulators can see in the cloud, in real time, exactly what’s happening with the pre-agreed-upon endpoints and safety signals,” Makary said.

The trial that’s up and running is the phase II TRAVERSE trial, sponsored by AstraZeneca, of acalabrutinib (Calquence) plus venetoclax (Venclexta) and rituximab in patients with treatment-naive mantle cell lymphoma. The two participating sites are the University of Texas MD Anderson Cancer Center and the University of Pennsylvania.

The other trial is the phase Ib STREAM trial, sponsored by Amgen, of tarlatamab (Imdelltra) in patients with limited-stage small cell lung carcinoma, and site selection is in process, according to the FDA.

Paul Burton, MD, PhD, chief medical officer of Amgen, said during the press briefing that conducting “pragmatic clinical trials does not mean conducting medical research with less rigor.”

FDA said it worked with sponsors to establish the criteria for reporting signals in real time and has since received and validated signals in the AstraZeneca trial through Paradigm Health.

Jeremy Walsh, chief artificial intelligence (AI) officer at the FDA, said an agency team began the initiative in June of last year, and subsequently began conversations with AstraZeneca and Amgen.

“I believe at the first meeting when we said what we wanted to do, it took a couple of minutes for people to be like, you want to not see all the data? You just want to see certain pieces, or the signals of the data?” Walsh said during the briefing.

He said that “after a series of meetings, we were able to get past that,” with the initiative kicking into gear by the end of last year and with the “whole process turned on and live this month.”

Walsh noted that “this is the start. This is probably not where we end up, but this is the start.”

Public comment on the request for information will be accepted until May 29, 2026, and final pilot selections will be made in August, the FDA said.

The agency has taken a number of steps to expedite the drug approval process on Makary’s watch. That includes reducing the number of required pivotal clinical trials from two to one, and proposed guidance to allow Bayesian designs in clinical trials.

Makary also mentioned a new AI tool that the agency will start using “very soon” that he says will shave 2 months off decision time for all drug reviews.

He also touted his Commissioner’s National Priority Voucher program that has resulted in seven decisions, with another 21 products selected for such review, including three psychedelic compounds announced last week.

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