Gender Bias in Studies for FDA Premarket Approval of Cardiovascular Devices
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WOMEN + HEART DISEASE (J ROBINSON, SECTION EDITOR)
Gender Bias in Studies for FDA Premarket Approval of Cardiovascular Devices Sanket S. Dhruva & Esme B. Cullen & Rita F. Redberg
Published online: 24 April 2014 # Springer Science+Business Media New York 2014
Abstract 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 understudied. 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.
Keywords FDA . Device regulation . Women
This article is part of the Topical Collection on Women and Heart Disease S. S. Dhruva Division of Cardiovascular Medicine, Department of Internal Medicine, University of California, Davis, Sacramento, CA, USA E. B. Cullen School of Medicine, University of California, San Francisco, San Francisco, CA, USA R. F. Redberg (*) Division of Cardiology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA e-mail: [email protected]
Introduction: Attempts at Progress in Reducing the Historical Exclusion of Women from Clinical Trials Over the past 30 years, numerous national organizations have noted the lack of women in clinical trials and have made attempts to increase the representation of women [1, 2]. In 1985, the US Public Health Service Task Force acknowledged that the lack of research on women’s health had compromised available information and, as a result, the quality of care for women. In 1988, the National Institutes of Health (NIH) formulated a policy promoting inclusion of women and minorities in all federally funded research. The FDA also responded to this issue by recommending in 1988 that studies examine the safety and effectiveness of drugs and devices between population subgroups, including by gender, age, and race. These advances were inspired by increasing awareness of the biological basis of sex differences in disease and growing evidence that outcomes in men and women for medical interventions can be markedly dissimilar. In 1990, the US General Accounting Office and NIH noted “little progress” in increasing representation of women in study populations and stratification of data by sex [3]. The NIH responded by creating an Office of Research on Women’s Health and requiring the inclusion of women in studies (unless there was a
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