FDA announces pilot of first "real‑time" clinical trial to speed drug development

Food and Drug Administration Commissioner Marty McCary announced onstage that the agency has launched a pilot "real‑time" clinical trial that will stream pre‑agreed safety signals and clinical endpoints to FDA reviewers in the cloud while the trial is running. McCary said the initiative is meant to reduce what he described as ‘‘dead time’’ in drug development and speed regulatory decisions without sacrificing safety.

"Very few people know that 45% of the drug development time is dead time," McCary said, adding that some sponsors still submit massive application packages — at one point he referenced an application of "66,000,000 pages" — and that the agency aims to cut delay by rethinking workflows and using modern technology. He said the pilot is "up and running" now and that the agency will initially receive both routine submissions and the live signals so reviewers have full visibility.

The pilot pairs FDA reviewers with industry sponsors, academic medical centers and a technology partner. Jeremy Walsh, the FDA's chief AI officer, described the prototype that underpins the pilot and said the agency will define the signals that must be reported with each sponsor. "We will take both the data submitted the routine way and the data that we're able to see in real time and we'll do both," Walsh said, underlining that the pilot is designed to run alongside existing regulatory processes.

Speakers from academic and industry partners framed the pilot as a step to broaden trial access and preserve scientific rigor. A senior MD Anderson representative, identified in the transcript as Dr. Jennifer Keaton Litton, said streamlining data collection could expand trial participation beyond large academic centers and help retain scarce research coordinators. Paul Burton of Amgen said pragmatic, real‑time approaches should complement—not replace—randomized trials and existing oversight.

Commissioner McCary also cited other reforms accompanying the pilot: reduced routine animal testing in some IND pathways, consideration of moving from two pivotal trials to a one‑trial baseline with Bayesian methods in specific cases, and use of AI tools McCary said would shave about two months from some filing timelines. He announced the agency has issued a Request for Information in the Federal Register to solicit input on scaling the approach and IRB reforms.

In a question‑and‑answer session, reporters pressed the FDA on safety and implementation. Arthur Jones of ABC News asked whether the agency risks missing safety signals or will lack review time; McCary replied that safety remains the agency's top priority and that safety signals and endpoints will be mutually agreed with sponsors. Maisha of Pink Sheet asked whether the optional pathway depends on deeper IRB reforms; McCary said IRBs are a rate‑limiting step and floated wider use of central IRBs or faster local turnarounds as possibilities.

Officials also described internal modernization work intended to support the pilot. McCary said FDA consolidated dozens of legacy IT systems into single platforms, estimating about $120 million in annual savings, and plans to reinvest those savings into hiring scientists and new technologies to support the agency's reform agenda. The agency said it expects to publish more detailed announcements on phase‑1 and IND pathways in the coming weeks.

The pilot is explicitly a test: agency officials said they will reassess at the end of the pilot to determine what worked, what needs change, and how to scale while preserving review rigor and public‑health protections. The agency invited comments through the Federal Register RFI and other public channels.

The event closed after a short Q&A and a group photo; attendees were told the pilot is already active and that additional implementation details and staffing announcements are expected in the near term.