FDA commissioner Scott Gottlieb is using the final days of his brief term to scold the drug R&D world for failing to keep up. Widely praised for his work aimed at modernizing the research tech and strategies used to advance new drugs, Gottlieb says that drug developers aren’t taking advantage of the new, more efficient approaches to clinical work — and that needs to change.
It’s not just the drug makers, says Gottlieb. CROs, who do much of the heavy lifting in the clinic, share a considerable portion of the blame.
“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations,” noted Gottlieb in a statement. “In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable. We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.”
He goes on in a jargon-laden style:
New research paradigms are needed to break down barriers between real world data and clinical research, so that evidence can be shared rapidly to improve both domains across a learning health care system. For instance, more trials can incorporate data from electronic health records, and adopt electronic informed consent, to enroll more patients in clinical trials closer to where they live and work. This can reduce barriers to clinical trial participation and accelerate researchers’ ability to ask and answer important questions.
Gottlieb goes on with the latest in a series of guidances aimed at streamlining R&D. The list includes the use of computerized systems for oversight, advice on adding patients to trials with more “challenging conditions,” to make trials better reflect real world conditions and more about avoiding animals in drug development work.
The industry has been cheering Gottlieb and the FDA on for this kind of work. Now Gottlieb, who winds up his tenure at the agency at the end of this month, wants the biopharma world to put it to practice.
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