Diversity action plan

What does Diversity action plan mean in clinical research?

The Food and Drug Omnibus Reform Act of 2022 (FDORA) added diversity action plans to the Federal Food, Drug, and Cosmetic Act. For a Phase 3 study, or another pivotal study of a new drug, the sponsor must submit a plan that includes its goals for enrollment, its rationale for those goals, and an explanation of how it intends to meet them.^⁠[1]

The plan is submitted in the form FDA specifies in guidance, no later than the date the sponsor submits the pivotal protocol. FDA may waive the requirement based on disease prevalence, impracticability, or a public health emergency. The requirement, and a parallel one for device studies, applies only to studies that begin enrollment more than 180 days after FDA publishes final guidance on diversity action plans.^⁠[1]

Why it matters for enrollment: goals written at the protocol stage are met, or missed, at sites. That makes a site's real reach into the populations named in the plan a fair feasibility question, including patients at community clinics and health centers who are rarely offered trials.

Practical note: a site can support a sponsor's plan by tracking who was identified, contacted, pre-screened and enrolled, so gaps show up while there is still time to change outreach. Bond's dashboard reports each of those stages, and Identify screens patient records in the EHR against the study's criteria rather than relying only on patients a coordinator already knows.