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

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. 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.