The Food and Drug Omnibus Reform Act of 2022 (FDORA) implemented new requirements for clinical trial diversity. Sponsors of late-stage drug and device trials must submit “diversity action plans” (DAPs) outlining their diversity goals for enrollment in the clinical study, the rationale behind those goals, and their strategies to achieve them. Therefore, the MRCT Center is developing a model DAP template, based on the MRCT Center’s Recruitment Strategy Document Template.
We have already identified important themes and considerations that will enhance the effectiveness and impact of these DAPs. To strengthen the completeness and applicability of this initiative, the MRCT Center is actively gathering DAPs from trial sponsors. If you have one or more examples of a DAP template that you would be willing to share, please email hahmed@bwh.harvard.edu. We will anonymize and use only to build the best DAP template possible.
We appreciate your continued collaboration and commitment to advancing diversity in clinical trials.