Preparing Updates to IRB and Recruitment Processes for the Upcoming FDA DEI Mandate

The Food and Drug Administration (FDA) will soon release requirements on Diversity Action Plans for clinical trials. Incorporating comprehensive Diversity, Equity, and Inclusion (DEI) strategies into trial planning, design, and execution enhances representation, optimizes health equity, and strengthens site selection, recruitment, and ethical review.

On Oct. 9, 2024, a WCG panel comprised of Emery Brandy, senior manager, client delivery, Olga Balderas, IRB regulatory chair and vice chair, and Amy Thue, associate director, project management, hosted a webinar centering their discussion on the DEI mandate, upcoming trends, and crucial elements needed for IRB and the recruitment process. This blog is a recap of that conversation.

Diversity Action Plan (DAP) Guidance

The Diversity Action Plan (DAP) guidance focuses on increasing enrollment of historically underrepresented populations in clinical studies to enhance the generalizability of evidence for the larger population.

The session began with a discussion of DAP’s goal: making research findings applicable to a broader audience. This initiative involves everyone in the clinical research ecosystem, from pharmaceutical and biotechnology companies to healthcare providers and research site staff.

1. Clinical Studies Requiring DAPs
   DAPs are mandatory for Phase III and other pivotal drug studies. The FDA suggests early submission of these plans, ideally by the end of Phase II.
2. Addressing Diversity in DAPs
   Sponsors are encouraged to leverage demographic registries, surveys, and published literature to inform their enrollment goals. It is also important to consider various diversity factors, including geographic location, disabilities, socioeconomic status, pregnancy, and comorbidities.
3. The Content of the DAP
   The content included in a DAP could be, but is not limited to, enrollment goals, rationales, and measures that sponsors can take to achieve their diversity goals. Specific strategies include community engagement, participant awareness, and improving access by limiting exclusion criteria and selecting diverse sites. The FDA expects submissions to be succinct— around ten pages. Additionally, all information must be available in consumer-friendly language on company websites and linked to recruitment websites.
4. Timelines for DAP Submission
   For drug studies, DAPs must be submitted to the relevant Investigational New Drug (IND) application by the protocol submission date for Phase III studies. For device studies, requirements vary depending on whether the study involves significant or non-significant risk devices. Given the importance of diverse enrollment, full or partial waivers will only be granted in rare instances.

Important Dates

• Sept. 26, 2024: Cutoff for comments submission.
• June 2025: Expected issue date for final guidance.
• December 2025: DAP requirements take effect.

The DEPICT Act

The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act passed in December 2022 by the United States (U.S.) Congress. This legislation holds sponsors accountable for diversity in their trials. If sponsors cannot meet their diversity goals, they must discuss the challenges with the FDA.

Current measures mainly focus on racial and ethnic diversity. Other underrepresented groups, such as LGBTQIA+, older populations, and those with rare diseases, also need more inclusivity.

Improving Diversity in Participant Recruitment and Retention

1. Sustained Community Engagement
   Community outreach increases clinical research awareness and fosters inclusivity. Effective strategies include:
   • Attending Walks and 5Ks: Engaging in local events to build relationships and increase visibility.
   • Putting Up Flyers: Informing the public by placing flyers in key locations.
   • Referral Provider Networking: Partnering with healthcare providers in diverse communities for participant referrals.
2. Study Materials in Native Languages
   Providing materials in multiple languages and including representational imagery fosters inclusion and relatability. Continuous support throughout the consent process ensures participants are well-informed.
3. Reducing Participant Burden
   Participating in clinical trials is often time-consuming and poses challenges for participants, particularly for marginalized communities. Thus, it’s important for clinical research stakeholders to consider steps to reduce the burden of participation. Solutions include
   • Providing Stipends and Reimbursements: Compensating for transportation and incidental costs.
   • Reducing In-Person Visits: Offering remote alternatives where possible.
   • Clear Instructions and Support: Ensuring participants receive comprehensive instructions and have a point of contact for questions.

On the Horizon

WCG is committed to supporting clients, sponsors, and sites in building trust with participants through dedicated engagement, frequent communication, creative study materials, and efficient data management. True recruitment success transcends meeting diversity quotas; it involves serving the community and ensuring that necessary treatments reach those who need them most.

By incorporating these strategies, marginalized populations can be better represented in clinical studies, leading to more inclusive medical treatments. Let’s move beyond numbers, empower communities, and elevate clinical research.

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