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CDER Director Calls for Bridging Clinical Research, Health Care Enterprises

Posted 04 April 2018 | By Zachary Brennan 

CDER Director Calls for Bridging Clinical Research, Health Care Enterprises

Clinical research and health care enterprises must be better linked to curb unsustainably high costs, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), told attendees Wednesday at the Bridging Clinical Research and Clinical Health Care conference at the National Harbor, MD.

The call to action comes as the cost of running clinical trials and the complexity of such trials continue to increase, particularly as somewhere between 50% and 80% of eligible patients are not being recommended for clinical trials that could help, Badhri Srinivasan, head of global development operations at Novartis, said.

Woodcock also called for more collaborative learning, noting: “It’s easy to forget who this is all for: People who need treatment and wellness and those who take care of them.”

She mentioned that FDA is actively looking for real-world evidence demonstration projects to “in some way inform new information on already marketed drugs,” but companies’ imaginations should not be bounded by pharmaceutical development because that can be “the hardest space as there is so much at stake” with expensive assets coming through companies’ pipelines.

Information collection must be integrated into the life flow of patients, she said, noting that some of the patient-reported outcome efforts FDA sees are “too complicated” or “too wonky … we have to work the patient into the center of this change.”

She also called for informed consent and randomization to be done in a digital environment, adding that some have suggested that big data will somehow trump randomization. “We don’t know enough about biology. Sorry, it’s true,” she said.

And do not expect the National Institutes of Health (NIH) to take the lead on this bridging, Woodcock added, noting NIH’s other incentives and pressures to conduct early basic research.

When asked why companies are often so cautious in pushing the boundaries on clinical trial innovation,
Woodcock noted that often drugs coming up for their first approval are part of a larger investment, so if sponsors are not cautious, then issues with meeting regulatory requirements can arise. But she also said that sponsors can get more creative once treatments are already on the market and in other areas of research that do not involve winning approval for an initial indication.

“Whatever pilots or changes that we try to make in this bridge, one of the most important things is feeding that information back to patients and [medical] practitioners,” she added. “We need to make them full participants instead of marginalizing them.”

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