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Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community.
Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community. As part of its 21st Century Cures Initiative, the House Energy & Commerce Committee called on representatives of industry and academia to present strategies for reducing regulatory oversight, speeding up clinical research processes, and utilizing technology to better understand the potential benefits and risks of promising new treatments.
Roy Herbst, chief of medical oncology at the Yale Cancer Center, described how a public-private partnership is organizing an innovative multi-center lung cancer study. The program features a master protocol for all sites, which promises to streamline patient enrollment, gain operational and cost efficiencies, and produce more consistent and transparent results.
Jay Siegel, chief biotechnology officer at Johnson & Johnson, noted that earlier approval of new therapies can be supported by increased use of data from electronic health records to help uncover adverse events in the post-approval arena. Clinical trial networks formed by academia, patient groups and biopharma companies can form research networks able to conduct adaptive trials to study many therapies. And more patient engagement can help develop patient-reported outcomes and risk-benefit assessment and diversify enrolment into clinical trials.
An important strategy for streamlining research is to reduce redundant oversight by Institutional Review Boards (IRBs), said Sundeep Khosla, dean for clinical and translational science at the Mayo Clinic. IRB “reciprocity” and “reliance” should enable the multiple centers participating in a large study to accept protocol approval and changes from a primary IRB. Paula Brown Stafford, president for clinical development at Quintiles, similarly backed centralized ethics committee approvals, standardization of clinical trial data, and greater use of real-world patient information to identify target subpopulations and inform clinical trials.
In addition to encouraging these strategies, all the participants urged Congress to increase support for clinical research networks, biomarker testing and other strategies through increased funding for the National Institutes of Health.
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21st Century Cures Initiative
House Energy & Commerce Committee
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