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Research Letter
September 2017

Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices

Author Affiliations
  • 1Robert Wood Johnson Foundation Clinical Scholars Program, Yale University School of Medicine, New Haven, Connecticut
  • 2Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 3Veterans Affairs Connecticut Healthcare System, West Haven
  • 4Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut
  • 5Women’s Health Research at Yale, Yale School of Medicine, New Haven, Connecticut
  • 6Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 7Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut
  • 8Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut
  • 9Associate Editor, JAMA Internal Medicine
  • 10Division of Cardiology, Department of Medicine, University of California-San Francisco School of Medicine, San Francisco, California
  • 11Philip R. Lee Institute for Health Policy Studies, University of California-San Francisco School of Medicine, San Francisco, California
  • 12Editor, JAMA Internal Medicine
JAMA Intern Med. 2017;177(9):1390-1391. doi:10.1001/jamainternmed.2017.3148

Women, the elderly, and minorities have been underrepresented in clinical trials.1-3 Risks and benefits of medical therapies, however, can vary based on these patient characteristics. The 2012 Food & Drug Administration (FDA) Safety and Innovation Act sought to address this issue by requiring the agency to initiate a plan that increases enrollment and clinical data for these important patient groups. This requirement led to the 2014 FDA Action Plan.4 We characterized enrollment reporting and evaluation of device safety and effectiveness for women, the elderly, and minorities for all 2015 premarket approval (PMA) devices, which undergo the most rigorous FDA review.

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