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Report calls on FDA to lead task force on post-approval trials

BY: KATHERINE ELLEN FOLEY | 11/14/2023 03:48 PM EST | UPDATED 11/15/2023 10:28 AM EST

The nonprofit Reagan-Udall Foundation that advises the FDA is recommending the agency lead an inter-agency and industry task force to streamline and strengthen post-approval studies of drugs and devices.

For a variety of reasons, many post-approval studies are never completed or take years longer than expected and FDA Commissioner Robert Califf said Tuesday that data obtained from these studies could be crucial in increasing the life expectancy of Americans, and provide other important health benefits.

“I bug the heck out of people about declining life expectancy and all the things that go with it,” Califf said at the Friends of Cancer Research annual meeting. “I don’t think it’s really the FDA’s responsibility, but I think we should be asking every day: ‘What are we contributing to turn this around?’”

The foundation’s recommendation on the creation of a new task force on post-marketing trials is in a new report out Tuesday, led by Dr. Richard Schilsky, former chief medical officer and executive vice president of the American Society of Clinical Oncology. The report concluded that a new task force could identify ways that these trials can be simplified and integrated into patient care without being an undue burden on clinicians.

“Gaps … remain in the clinical evidence base for many products because the populations with the greatest disease burdens are often underrepresented in clinical trials, or because trials to support initial marketing applications focus on very narrow potential indications,” the report noted.

Pre-approval clinical trials work well to establish a medical product’s safety and efficacy, but after it receives FDA clearance questions are “left on the table,” Califf said. Additional data on real-world use could help answer key questions that pre-approval clinical trials can’t answer, like the ideal duration of a treatment or how one treatment compares to others.

The new report cautioned that implementing its recommendations may require additional funding from industry and the federal government. “It’s understandable that industry is for profit, [and] there’s not an incentive to answer these questions,” Califf said.

CORRECTION:Dr. Richard Schilsky is the former chief medical officer of the American Society of Clinical Oncology. Due to an editing error, a previous version of this story used an incorrect title.
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