The under-representation of women in cardiovascular clinical trials: State-of-the-art review and ethical considerations

作者：Sonya Burgess, Sarah Zaman, Cindy Towns, Megan Coylewright, Fathima Aaysha Cader · 发表于：American Heart Journal · 年份：2024 · DOI：10.1016/j.ahj.2024.12.011 · 被引用次数：20 · 研究领域：Sex and Gender in Healthcare、Health and Medical Research Impacts、Acute Myocardial Infarction Research

• The Status quo: The under recruitment of women to clinical trials has an impact on the generalizability of trial data, limiting the detection of sex-based interactions and appropriate sex specific recommendations. • The clinical implications: Addressing under-recruitment of women is an important step toward closing the data gap for women with cardiovascular disease, with the potential to improve outcomes and achieve equity of care for women with cardiovascular disease. • The power of change to address disparity and data gaps: Strategies to address representation of women as investigators and authors in these trials are needed, as higher inclusion of women has been shown to increase recruitment of women as participants. • The timing of this article: the Diversity Action Plans for clinical trials announced by the United States (US) Food and Drug Administration (FDA) in 2024, with requested public comments, the inclusion of MINOCA recommendations in the ESC 2024 guidelines, 2021 US Chest Pain guidelines, and the 2023 US guidelines for the Management of Chronic Coronary Disease, all demonstrate the need for increased awareness of the under-representation of women, and solutions for change. This review describes and evaluates the representation of women in cardiovascular randomized controlled trials (RCT), it reports significant under-representation of women in clinical trials both as participants and researchers and discusses the ethical implications of under-representation. Th...