Regulatory approval of high-risk cardiovascular devices is on the basis of clinical studies submitted with a premarket approval application. Failure to publish many of these studies in peer-reviewed literature, and major discrepancies between premarket approval submissions and those studies that are published, raise important questions for clinicians and other stakeholders.
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D.B.K. is a consultant to the FDA Circulatory Systems Advisory Panel and is funded in part by a Paul Beeson Career Development Award in Aging Research (K23AG045963). D.E.C. receives salary support from Harvard Clinical Research Institute, an academic research organization that performs contracted research for industry-funded and government-funded clinical trials, and research support from Boston Scientific and Medtronic.
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Kramer, D., Cutlip, D. Trust and transparency in clinical trials of medical devices. Nat Rev Cardiol 12, 503–504 (2015). https://doi.org/10.1038/nrcardio.2015.112
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DOI: https://doi.org/10.1038/nrcardio.2015.112
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