Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
Icahn School of Medicine at Mount Sinai, New York, New York.
JACC Cardiovasc Interv. 2019 Feb 11;12(3):301-308. doi: 10.1016/j.jcin.2018.10.048.
Women have historically been underrepresented in clinical trials evaluating cardiovascular devices. Existing initiatives through government agencies have made some progress, but contemporary rates of female clinical trial participation leave much room for improvement. This position paper provides a narrative review and investigates reasons for the underrepresentation of women in cardiovascular trials. The observed differences in safety and/or effectiveness of devices in women warrant a campaign to increase their trial participation with the aim of better understanding and improving outcomes. The authors propose a multifaceted approach to increasing female enrollment through the development of a national public awareness and education campaign aimed to inform women, clinician-providers, and clinical research personnel of these differences. Finally, the authors visit some barriers relevant to women and recommend ways to facilitate their participation in clinical trials through multistakeholder engagement.
女性在评估心血管设备的临床试验中历来代表性不足。政府机构的现有举措已经取得了一些进展，但女性参与临床试验的比例仍然有很大的提升空间。本立场文件提供了一个叙述性综述，并探讨了女性在心血管试验中代表性不足的原因。女性在设备安全性和/或有效性方面的差异表明，需要开展一项运动来增加她们的试验参与度，以更好地了解和改善治疗结果。作者提出了一种多方面的方法，通过开展全国性的公众意识和教育活动来增加女性的参与度，旨在让女性、临床医生和临床研究人员了解这些差异。最后，作者讨论了一些与女性相关的障碍，并建议通过多利益相关者的参与来促进她们参与临床试验。
