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.
Dhruva SS, Mazure CM, Ross JS, Redberg RF. Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices. JAMA Intern Med. 2017;177(9):1390–1391. doi:10.1001/jamainternmed.2017.3148
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