Abstract
Within the United States, cardiovascular disease is the leading cause of death. There are well-established inequities in cardiovascular care; individuals from medically underserved populations-including those with low socioeconomic status, rural populations, a plethora of racial and ethnic groups, women, and those living with disabilities-are often at increased risk of cardiovascular morbidity and mortality. Despite their critically unmet needs, these populations remain underrepresented within cardiovascular clinical trials, therefore deepening inequities in cardiovascular care. The inclusion of representative populations within cardiovascular clinical research ensures that data derived from clinical trials translate into effectiveness for all populations, particularly as cardiovascular therapeutics move toward personalized approaches. In this article, we review the importance of including underserved populations in cardiovascular clinical research and the key barriers to their participation. We explore system-level strategies that have only recently demonstrated large-scale feasibility within the cardiovascular research paradigm, such as community-engaged research and clinical trial decentralization, to increase access and engage underserved communities. Decentralizing clinical trials can overcome many of the barriers associated with performing clinical trials at traditional study sites. Additionally, increasing clinical trial workforce diversity and including community clinicians and stakeholders during study design, recruitment, and administration can improve representation within clinical trials. Finally, we propose a holistic approach to improving the diversity of cardiovascular clinical trial participants through the application of the hub-and-spoke organizational model.