Improving representativeness in trials: a call to action from the Global Cardiovascular Clinical Trialists Forum
Lynaea Filbey, Jie Wei Zhu, Francesca D’Angelo, Lehana Thabane, Muhammad Shahzeb Khan, Eldrin F. Lewis, Manesh R. Patel, Tiffany M. Powell‐Wiley, J. Jaime Miranda, Liesl Zühlke, Javed Butler, Faı̈ez Zannad, Harriette G.C. Van Spall
Abstract
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.