Tool
Published: September 4, 2024
The Model Diversity Action Plan (DAP) was developed in response to the FDA’s latest directive aimed at improving diversity within clinical trial participation. Built upon the MRCT Center’s Recruitment Strategy Document, this framework supports compliance with FDA standards. The Model DAP also outlines clear objectives that extend beyond the FDA’s initial guidelines, emphasizing a broader international viewpoint. Sponsors are encouraged to delineate specific regions and countries targeted for trial inclusion, detailing proactive strategies designed to overcome obstacles related to diverse, inclusive, and equitable recruitment practices, particularly outside the United States. While these additional details may not always be mandatory for FDA submissions, they are pivotal in fostering a comprehensive approach to trial design and execution. Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion. This dynamic document will evolve as the FDA guidance is finalized.