Gender Bias in Studies for FDA Premarket Approval of Cardiovascular Devices
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Women have been under-represented in clinical trials for several decades and a large amount of medical knowledge is based on data in men which are extrapolated to women. Over the past few decades, attempts have been made to increase our understanding of risks and benefits of drugs and devices in women, but the latter have been under-studied. The premarket approval process is used by the FDA to evaluate the safety and effectiveness of high-risk medical devices. The safety and effectiveness of a substantial minority of these devices has been shown to differ by sex. However, pivotal studies of these devices that lead to FDA approval often do not include adequate numbers of women nor do most stratify outcomes by sex. Numerous attempts and initiatives to increase availability of sex-specific data have improved this evidence gap modestly, but additional policy changes are necessary to optimize safety and effectiveness evaluation in women.
KeywordsFDA Device regulation Women
Compliance with Ethics Guidelines
Conflict of Interest
Sanket Dhruva declares no conflicts of interest. Esme Cullen declares no conflicts of interest. Rita Redberg declares no conflicts of interest.
Dr. Redberg is a current member of the FDA Circulatory System Devices Panel.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by the author.
Papers of particular interest, published recently, have been highlighted as: •• Of major importance
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