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心血管临床试验中女性代表性不足:最新综述与伦理考量

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

作者信息

Burgess Sonya, Zaman Sarah, Towns Cindy, Coylewright Megan, Cader F Aaysha

机构信息

Department of Cardiology, Nepean Hospital, Sydney; University of Sydney, New South Wales, Australia.

Department of Cardiology, Nepean Hospital, Sydney; Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia; Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.

出版信息

Am Heart J. 2025 Apr;282:81-92. doi: 10.1016/j.ahj.2024.12.011. Epub 2024 Dec 27.

DOI:10.1016/j.ahj.2024.12.011
PMID:39733919
Abstract

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. The under-representation of women as participants in cardiovascular RCTs is evident in trials investigating cardiovascular drugs, acute coronary syndrome, heart failure and interventional procedures and devices. Under-representation of women is also evident in the authorship of cardiovascular clinical trials and in trial leadership roles, and under-representation of women as trial investigators is independently associated with under- recruitment of women as trial participants. A notable lack of RCTs investigating conditions that disproportionately affect women is also evident, this triad of underrepresentation for women as participants, and investigators, and the lack of RCTs into conditions predominantly experienced by women, all contribute to the gender gap in cardiovascular outcomes. Better representation of women in clinical trials, in trial leadership and authorship is a key factor to address to equity, distributive justice and improve outcomes for women with cardiovascular disease.

摘要

本综述描述并评估了女性在心血管随机对照试验(RCT)中的代表性,报告了女性在临床试验中作为参与者和研究人员的代表性严重不足,并讨论了代表性不足的伦理影响。女性作为心血管RCT参与者的代表性不足在研究心血管药物、急性冠状动脉综合征、心力衰竭以及介入程序和设备的试验中很明显。女性在心血管临床试验的作者身份和试验领导角色方面的代表性也不足,女性作为试验研究者的代表性不足与女性作为试验参与者招募不足独立相关。明显缺乏针对对女性影响 disproportionately 的病症的RCT,女性作为参与者和研究者的这种代表性不足的三重奏,以及缺乏针对女性主要经历的病症的RCT,都导致了心血管疾病结果中的性别差距。在临床试验、试验领导和作者身份中更好地体现女性代表性是解决公平、分配正义以及改善患有心血管疾病女性的结果的关键因素。

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