Patient Diversity Work Group Pauses Metric Discussions to Discuss DEPICT Legislation and the FDA’s Diversity Plan
The AQC Patient Diversity Metric Development Work Group was scheduled to discuss member feedback about the draft site diversity assessment scoring tool at a meeting on April 14. However, the agenda quickly changed when the FDA released a new draft guidance entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” on April 13. During the meeting, the work group reviewed and discussed key aspects of the draft guidance. Work group member, Lori Abrams, Vice President, Patient Advocacy & Clinical Research Diversity at WCG, provided contextual background on how the FDA typically handles situations when insufficient safety and efficacy data has been collected from racial and ethnic subgroups. She stated that the draft guidance signals that the FDA is shifting to a proactive approach that emphasizes including underrepresented populations in all phases of clinical trials – not just post approval studies. Abrams shared insights from her extensive experience of developing Diversity Plans and bringing de novo sites into clinical research. Finally, she noted that while FDA guidances are not mandatory requirements, the “Diverse and Equitable Participation in Clinical Trials Act” or the “DEPICT Act” – introduced to the US House on February 3, 2022 – if passed, will direct the FDA to amend certain regulations to increase clinical trial diversity.