Powering Diverse and Inclusive Clinical Trials

The Food and Drug Administration (FDA) will soon require clinical trial sponsors to submit a plan for improving diversity among clinical trial participants. While enhancing diversity, equity and inclusion (DEI) has been a topic of discussion in the industry for many years, sponsors will soon have an imperative to act.

The omnibus spending bill, which was passed in December 2022, advances current guidance by requiring sponsors to submit diversity action plans for phase 3 or pivotal clinical trials by the time they submit the protocol. The plans must include the sponsor’s goals for enrollment by age, sex, race and ethnicity; rationale for those goals; and how the sponsor plans to meet them.

To effectively recruit and engage diverse populations, sponsors need to address common barriers that include access, trust and awareness as well as financial and logistical concerns. As they prepare for full implementation of the new requirements, sponsors will need to re-think patient recruitment and engagement planning to ensure alignment with DEI goals and objectives. Key considerations include the use of data, technologies and engagement platforms to accomplish these new regulatory requirements from the FDA.