Diversity Plans, Sharing for Meaningful Change

At the SCOPE meeting last month, the panel discussion “Operationalizing Diversity in Clinical Trials: Cross-Functional Capabilities Needed to Recruit, Track, & Adapt for Meaningful Change” included input for industry that supports this goal. As moderator Jason Gubb, a clinical operations consultant and former GSK head of global clinical sciences and operations, noted, “The goal [for diversity in clinical trials] is to go beyond intent and get real about making meaningful change. We don’t want a cookie-cutter approach and we don’t want a tick-the-box exercise.”

Jamie Brewer, MD, clinical team lead, Office of Oncologic Diseases, at FDA's Center for Drug Evaluation and Research (CDER), told attendees the best way to engage with FDA is to simply submit the diversity plan as early as possible in your clinical development plan. She explained, “We aren’t just checking the box that they are submitted. We are reviewing them and discussing them internally, reading your justifications for your enrollment goals, asking questions back…asking for you to maybe provide further justification or how the enrollment goal will be met or if it is appropriate.”

It is not a prescriptive but iterative process, which can include further meetings or interactions between FDA and the sponsor on how they are achieving and revisiting their clinical trial enrollment goals, providing retention goals or updates, as well as updates to ensure that goals are being met.

Brewer also noted that industry and FDA are “walking in uncharted territory.” She said that how industry goes about not reinventing the wheel, and utilize what it's learned from developing diversity plans and share in a way that is mutually acceptable to all stakeholders, is not in FDA’s wheelhouse. However, she believes that this resource-sharing would go a long way to help individuals at companies with their own oversight and planning.

Other such examples at SCOPE included:

• IQVIA’s “Advancing Diversity in Clinical Development through Cross-Stakeholder Commitment and Action. https://www.iqvia.com/insights/the-iqvia-institute/reports/advancing-diversity-in-clinical-development
• TransCelerate BioPharma’s Diversity of Participants in Clinical Trials Initiative, includes program-level and site-level toolkits. https://www.transceleratebiopharmainc.com/initiatives/diversity-of-participants-2/

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and can be reached at lhenderson@mjhlifesciences.com.