Department of Medicine, McMaster University, 20 Copeland Avenue, David Braley Research Building, Suite C3-117, Hamilton, ON L8L 0A3, Canada.
Research Institute of St. Josephs, St. Joseph's Healthcare Hamilton, 50 Charlton Ave E, Hamilton, ON L8N 4A6, Canada.
Eur Heart J. 2023 Mar 14;44(11):921-930. doi: 10.1093/eurheartj/ehac810.
Participants enrolled in cardiovascular disease (CVD) randomized controlled trials are not often representative of the population living with the disease. Older adults, children, women, Black, Indigenous and People of Color, and people living in low- and middle-income countries are typically under-enrolled in trials relative to disease distribution. Treatment effect estimates of CVD therapies have been largely derived from trial evidence generated in White men without complex comorbidities, limiting the generalizability of evidence. This review highlights barriers and facilitators of trial enrollment, temporal trends, and the rationale for representativeness. It proposes strategies to increase representativeness in CVD trials, including trial designs that minimize the research burden on participants, inclusive recruitment practices and eligibility criteria, diversification of clinical trial leadership, and research capacity-building in under-represented regions. Implementation of such strategies could generate better and more generalizable evidence to reduce knowledge gaps and position the cardiovascular trial enterprise as a vehicle to counter existing healthcare inequalities.
参与心血管疾病（CVD）随机对照试验的患者通常不能代表患有该疾病的人群。与疾病分布相比，老年人、儿童、妇女、黑人和原住民以及中低收入国家的人群在试验中的参与率通常较低。CVD 治疗的疗效估计主要来自于在没有复杂合并症的白人男性中产生的试验证据，从而限制了证据的普遍性。本综述重点介绍了试验参与的障碍和促进因素、时间趋势以及代表性的基本原理。它提出了在 CVD 试验中增加代表性的策略，包括最大限度地减少参与者研究负担的试验设计、包容性的招募实践和资格标准、临床试验领导的多样化以及代表性不足地区的研究能力建设。实施这些策略可以生成更好、更具普遍性的证据，以缩小知识差距，并使心血管试验企业成为应对现有医疗保健不平等的工具。
