Evaluating the Science of Diversity in Clinical Trials: Design and Goals of an American Heart Association Strategic Focused Research Network.

Abstract

Background: Clinical trials serve as the key evidence that shapes guideline recommendations and clinical practice. Despite long-standing recommendations by regulatory and funding organizations for representative trial enrollment, the underinclusion of women and individuals from diverse racial and ethnic populations in cardiovascular and dementia clinical trials persists. This undermines trust in research, threatens basic principles of fairness, and may limit the generalizability of trial results to broad patient populations.

Methods: To better understand how to foster more inclusive cardiovascular trial participation, the American Heart Association launched a Strategically Focused Research Network (SFRN) to study the Science of Diversity in Clinical Trials in 2022. The SFRN includes 5 Network Centers operating from Johns Hopkins University ("IMPACT"), Stanford University ("DIVERSE"), University of California Los Angeles ("iDIVERSE"), University of Southern California/Howard University ("ATRIL"), and the University of Pennsylvania ("BETTER"). Each Center is a partnership that includes an institution focused on the education of Black, Hispanic, American Indian, Native Hawaiian/Pacific Islander, and/or non-White students. Each Center has multiple projects with actionable results and is training at least 3 dedicated postdoctoral fellows. Additionally, a 6th Center ("TRAIN") led by faculty at Stanford and Morehouse Universities is facilitating formal fellowship training across the Centers.

Conclusions: Projects are ongoing and all 6 Centers are working on collaborative initiatives. These Centers are expected to provide valuable insights into clinical trial participation, including innovative conceptual frameworks to inform the diversification of clinical trial participation and novel recruitment and retention strategies that can be broadly disseminated.