Individuals who participate in randomized clinical trials should be representative of the patients who will be treated with the drugs under investigation. “Unfortunately, studies have consistently shown that women and those from racial and ethnic minority groups are consistently underenrolled in cardiovascular clinical trials relative to their disease burden in the population,” reports Erin D. Michos, MD, MHS, FACC, FAHA, associate director of preventive cardiology at Johns Hopkins School of Medicine.

To recruit diverse participants into cardiovascular trials, the research institution and individual investigators must develop and maintain trust with the community they are hoping to enroll, urges Elicia Preslan, MS, CIP, IRB Operations QA/QI manager of the Human Research Protections Program at Virginia Commonwealth University. “Trust-building with communities that have experienced systemic inequities and social barriers to healthcare should be seen as an ongoing process and something to maintain, not an end goal that can ever be fully achieved,” Preslan explains.

Preslan says researchers should consider using patient-centered and community-engaged approaches. “These are likely to be more successful because the research methods are designed in ways that build relationships and trust between participants, communities, and the researchers,” Preslan notes.

IRBs could ask study investigators where and how recruitment materials will be used (e.g., what parts of town or which schools), along with details about experience working with the proposed marginalized community. Further, the IRB could ask about input the study team sought and received from the community while designing the protocol, along with determining whether there is a monitoring plan that specifically includes analysis of the study’s progress toward meeting their race/ethnicity enrollment goals.

“IRBs could also work with study teams to develop a plan to provide results and information back to the participants or communities after the study is done,” Preslan suggests.

A working group for the American Society for Preventive Cardiology (ASPC) reviewed the literature regarding the inclusion of women and members of racial/ethnic groups into cardiovascular clinical trials, focusing predominantly on prevention trials, and discussed best practices for improving enrollment of diverse populations into trials.¹ There are established recommendations from the NIH and the FDA for the inclusion of women and underrepresented populations in clinical trials, “but the implementation piece to actually achieve that in clinical trial recruitment is often lacking,” explains Michos, the lead author of the ASPC’s practice statement.

For individuals, barriers to study participation may include fear, mistrust, lack of awareness about ongoing trials, not being approached for participation, overly restrictive eligibility criteria, effects of social determinants on participation, and logistical challenges stemming from time or financial constraints.

To address these barriers, the ASPC practice statement recommends research teams include diverse research staff who are trained in implicit bias and cultural sensitivities. Study investigators should foster greater collaborations with researchers from underrepresented groups and regions, and engage community advisors. Finally, patients should provide input on trial design, recruitment, consent processes, and patient-facing materials. “Barriers to diverse trial enrollment can be overcome with patient and community engagement to help build trust, education about the benefits and importance of clinical trials, and the diversification of study team investigators,” Michos says.

REFERENCE

1. Michos ED, Reddy TK, Gulati M, et al. Improving the enrollment of women and racially/ethnically diverse populations in cardiovascular clinical trials: An ASPC practice statement. Am J Prev Cardiol 2021;8:100250.