SS Dhruva, RF Redberg
The Safety and Effectiveness of Medical Treatments can differ in men and women formany reasons related to different epidemiologic characteristics, physiology, and body size. In general, women have higher bleeding rates and procedural morbidity and mortality than men, which means that their risk/benefit ratios for many implanted medical devices can differ from men. Therefore, sex-specific safety and effectiveness data are necessary for informed patient decision making. In 2008, the US Food andDrug Administration (FDA) convened 2 work- shops on this topic that included multiple stakeholders, patient groups, medical device industry representatives, academia, and government officials. In December 2011, the FDA released a draft guidance informed by these workshops, entitled “Evaluation of Sex Differences in Medical Device Clinical Studies.”1 This document discusses the underrepresentation of women in medicaldevice clinical trials and provides recommendations for increasing enrollment of womenand performing sex-specific analyses.
For Full Commentary, Go to: JAMA, March 21, 2012