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Research Letter
April 2016

Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013A Cross-sectional Study

Author Affiliations
  • 1Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 2medical student, Yale University School of Medicine, New Haven, Connecticut
  • 3Robert Wood Johnson Foundation Clinical Scholars Program, Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 4Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut
  • 5Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut
JAMA Intern Med. 2016;176(4):551-552. doi:10.1001/jamainternmed.2015.8590

Selective publication of clinical studies supporting US Food and Drug Administration (FDA) approval of novel drugs and devices prevents patients and physicians from making informed decisions about these products.1,2 Among 149 novel therapeutics approved by the FDA between January 2005 and December 2011, a total of 326 of 380 (85.8%) supporting pivotal studies were published.3 In contrast, less than half of all studies supporting FDA Premarket Approval (PMA) of novel, high-risk cardiovascular devices between January 2000 and December 2010 were published, and more than one-fourth of these presented results in a manner discrepant with FDA reviews.4 It remains unknown whether contemporary practices of disseminating medical device research have improved in the wake of the 2007 FDA Amendment Act, which expanded the registration and reporting requirements on clinicaltrials.gov to explicitly include medical devices. We therefore examined the publication and reporting of studies supporting novel, high-risk cardiovascular devices approved by the FDA between January 2011 and December 2013, which account for approximately half of all FDA PMAs,5 along with potential predictors of publication, including study, device, and company characteristics.

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