Diversity, equity, inclusion, and access are necessary for clinical trial site readiness

Abstract

Clinical research has long struggled with diversity, equity, inclusion, and access (DEIA). Despite the increasing diversity of the U.S. population, marginalized groups continue to be underrepresented in clinical trials. The lack of representation in clinical trials has impeded innovation, compromised generalizability of evidence, and may undermine trust in the clinical trials enterprise [1]conclusions that FDA echoes in its guidance on diversity plans [2]. DEIA must inform clinical trials from design to dissemination to generate valid, generalizable evidence that meets the needs of an increasingly diverse population and addresses health inequities.In this commentary, we discuss select site readiness practices, outlined in a companion article [3], which are particularly relevant to promoting DEIA in clinical trials. This perspective focuses on race and ethnicity, though other aspects of diversity, such as ability, sex, gender, sexual orientation, and others, also are underrepresented in clinical research [1,4]. Addressing race and ethnicity is an opportunity to intentionally focus efforts on a long-standing area of exclusion in clinical trials. The companion article includes the full set of site readiness practices, methods for their selection, and a rationale for their use by clinical trial sites. Site readiness practices must include DEIA considerations to avoid perpetuating existing inequities and to help address known or suspected barriers to clinical trials accesssuch as language, transportation, or dependent care [5]. Additionally, site readiness practices should seek to address structural constructs perpetuated within the medical and clinical trial enterprise that impede progress on these issuesthrough insurance coverage, hiring practices, partnership with communities, and mentorship opportunities. To this point, improving DEIA should specifically and explicitly be expressed as both goals and metrics for progress. Effective DEIA efforts in research participation should begin early, during the design and budgeting stages. Site readiness often involves actions taken even before the project's conceptualization, such as modifying existing systems or policies. We believe that the site readiness practices discussed in this article (Table 1) support the development of a clinical research system that is intentionally inclusive, and therefore more closely aligned with the needs of patients.