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Bloomberg Law – FDA Cancer Chief Mulls NCI Partnership to Increase US Study Size

Bloomberg Law – FDA Cancer Chief Mulls NCI Partnership to Increase US Study Size

The National Cancer Institute could handle US enrollment of studies testing cancer drugs under a proposal floated by FDA’s cancer chief as part of a larger effort to improve clinical trials.


Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, proposed the idea Thursday as a potential solution to ensure the data used to approve cancer therapies in the US represent the nation’s population.


Drug companies have increasingly moved their clinical trials offshore, and both Pazdur and FDA Commissioner Robert M. Califf, who was on the same panel, said multiregional clinical trials are a good thing. But they should include research volunteers from countries from the pharmaceutical regulatory harmonization body known as ICH, Pazdur said.


“We’re not suggesting that all clinical trials have to be done in the United States, but there is a percentage that has to be done in the United States,” Pazdur said. “But we want representation from all of the ICH regions.”


The concern arises when a company submits a drug application based on a study run in a single country, especially as a lack of diversity in clinical trials continues to be a pressing challenge.


“One of my major issues here is why are people not doing these trials in the United States? If it’s cost, that might be a reasonable issue,” Pazdur said. Clinical trials eat up a large chunk of drug development costs, with a 2014 Health and Human Services analysis pricing oncology trials at $78.6 million.


But some companies are moving outside the US “because there’s a better therapy that is approved here in the United States, and they’re doing a randomized study against a known inferior therapy,” Pazdur said.


“This is particularly problematic,” he said. “People that go on clinical trials should be getting the best therapies. There’s an asterisk that says, ‘only available or only approved in your countries.’”


Pazdur said he would like to see the National Cancer Institute work more with companies, in partnership with the FDA, to help address these concerns.


“I don’t see why we wouldn’t have the NCI—and this has been done in other trials historically, but on a very limited extent—do the US enrollment of a clinical trial, and then have the company do ex-US enrollment to make sure that the trial is accruing very rapidly. But we would have the NCI coordinating the enrollment in the United States and then combining these databases.”


Clinical trials have long had a reputation for being clunky and bureaucratic, and Pazdur said he wants to collaborate more with Monica Bertagnolli, who took over as NCI director in October.


“We’ve made these trials way too complicated—just mind bogglingly complicated,” Pazdur said.


In a later session at the Friends conference, Bertagnolli didn’t specifically address Pazdur’s proposal about NCI handling US studies. However, she made clear improving the clinical trials process was a top priority and expressed an interest in working with the FDA, which she described as a partner in simplifying the clinical trials process.


“There’s too much bureaucracy,” she said. “We really have to look at how we can address what the patient needs, first and foremost, in the most efficient, cost effective and, above all, inclusive possible way.”