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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

Energy and Commerce Subcommittee Holds Hearing on Clinical Trials

July 11, 2014—The House Energy and Commerce Subcommittee on Health July 9 held a hearing titled Modernizing Clinical Trials. The hearing, part of the committee’s 21st Century Cures initiative, focused on ways to make trials more efficient and effective by leveraging recent advances in science and technology.

Subcommittee Joe Pitts (R-Pa.) opened the hearing by identifying a number of deficits in the current clinical trials system, including the expanding cost and size of trials, difficulty in identifying potential participants, research fragmented across clinical research organizations and sites, and a slow adoption of technology such as electronic health records and web-based platforms.

“This expensive and antiquated clinical trials model is simply not acceptable in the 21st century,” Chairman Pitts said, adding, “Researchers and physicians are going to have to strengthen the recruitment and retention of volunteers for their trials, adopt new technologies, and, above all, collaborate to build efficient and effective clinical trials.”

Roy S. Herbst, M.D., Ph.D., chief of medical oncology and associate director for translational research, Yale Cancer Center, told the subcommittee, “Clinical trials need to be modernized for the molecular age.” He described the Lung-MAP project, on which he is a co-principal investigator, as “an innovative, groundbreaking clinical trial to facilitate efficiencies and advance the development of targeted therapies for squamous cell cancer of the lung.” He made several recommendations for the committee’s consideration, including:

  • Establishing an increased rate of patient reimbursement to support and incentivize trials that incorporate biomarker evaluation;
  • Developing a framework of policies governing advanced diagnostics, including the pre-market and post-market authorities for data generation and requirements and rates for reimbursement;
  • Examining incentive structures and processes to facilitate data generation/sharing and collaboration; and
  • Providing sustained funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) with a diminution of the constraints on education, travel and paper work that make these projects even more complicated.

Sundeep Khosla, M.D., director, Center for Clinical and Translational Science, Mayo Clinic, described NIH’s National Center for Advancing Translational Sciences (NCATS), which he said is “facilitating new drug discovery, providing the tools to better understand human physiology and disease, discovering new biomarkers, and … enhancing the conduct of clinical trials.” He told the subcommittee NCATS is working to modernize the clinical trials process at a national level by funding Clinical and Translational Science Awards (CTSAs) at 62 sites around the country, “essentially creating a network of potential clinical trial sites.”

Dr. Khosla urged Congress to continue supporting NCATS and the CTSAs “through ongoing and, if possible, enhanced funding.” He also called on Congress to help develop policies that encourage institutional review boards (IRBs) to have greater reciprocity with other institutions, provide funding and incentives for developing greater interoperability of medical records across the country, and develop policies for greater harmonization of regulations across federal agencies and across states.

Robert J. Meyer, M.D., director, Virginia Center for Translational and Regulatory Sciences (VCTRS), University of Virginia School of Medicine, emphasized the need to develop more “effective, durable clinical trials networks” and master protocols. 

Aaron S. Kesselheim, M.D., J.D., M.P.H., assistant professor of medicine, Harvard Medical School, and director, Program on Regulation, Therapeutics, and Law (PORTAL), Brigham and Women's Hospital, explained that expedited approval programs have become common at the FDA, and noted that 26 of the 39 new drugs approved in 2012 qualified for at least one of these expedited programs.

Dr. Kesselheim said, “When drugs and high risk medical devices are approved without being subject to rigorous testing, it puts patients at risk.” He noted “the prospect that researchers may be able to design new ways of conducting clinical trials of investigational drugs is exciting, and I hope that the best of these truncated designs are indeed proven to work and provide the same level of confidence as standard randomized trials… However, the FDA already has the flexibility in its laws and regulations to integrate validated innovative study designs and validated biomarkers into its review process… If regulators and others in the medical community are still skeptical about certain biomarkers and clinical trial designs, it’s probably because the science supporting them is still in its infancy, in which case forcing approval of the drugs or devices to which they are applied would be dangerous for patients and problematic for physicians.”

Other witnesses included Jay P. Siegel, M.D., chief, Biotechnology Office, and head, Scientific Strategy and Policy, Johnson & Johnson; William V. Murray, president and CEO, Medical Device Innovation Consortium; and Paula Brown Stafford, M.P.H., president, Clinical Development, Quintiles.

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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Jason Kleinman
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Telephone: 202-903-0806
Email: jkleinman@aamc.org