Building Your Toolkit: How to Operationalize FDA Guidance on Diversity
The recent FDA guidance on diversity in clinical trials, released in June 2024, marks a pivotal step toward more inclusive clinical research. This guidance requires clinical trial sponsors to submit a diversity action plan (DAP) for certain studies as part of an ongoing effort to increase the recruitment and retention of underrepresented populations in clinical research. Our recent webinar with PCM Trials and EmVenio Research, a PCM Trials company, took a look at operationalizing FDA guidance on diversity, exploring the tools and approaches available to make truly inclusive and accessible trials a reality.
Read some of the key takeaways below or click to watch the full webinar.
Why Diversity Matters in Clinical Research
The goal of diversity in clinical trials is not new; however, the FDA’s recent guidance further emphasizes the need for diverse representation in research. Clinical trials that overlook diversity risk delivering incomplete results, especially as different patient populations may respond uniquely to treatments. By recruiting a patient population that mirrors the broader demographic of the disease being studied, researchers can better ensure new treatments are optimized for all potential users.
Stephanie Hitchcock, Director of Project Management at PCM Trials, highlighted that diverse clinical trials can deliver data that reflects a treatment’s impact across racial and ethnic groups. This representation is essential for equity in healthcare, as well as for the efficacy of therapies that serve a wider population.
The FDA’s Diversity Guidance: A Roadmap for Action
The FDA’s guidance on DAPs aims to support greater diversity in trial recruitment by requiring sponsors to document their strategies and address any exclusion criteria that could limit diversity. While this guidance is not a mandate, it signals an evolution in clinical trial standards that could one day impact regulatory decisions. As Kris Booth, Director of Strategic Operations at EmVenio, explained, the FDA guidance sets the expectation that sponsors proactively consider the geographic and demographic spread of their participants.
PCM Trials and EmVenio have positioned themselves as strategic partners in addressing diversity requirements through a commitment to optionality and reach. This approach enables sponsors to meet participants where they are, facilitating research access for those who might otherwise be excluded due to location or other barriers to participation.
Operationalizing Diversity in Trials
One major takeaway from the discussion was how innovative trial designs can support recruitment and retention goals. By leveraging community-based research models, PCM Trials and EmVenio bring trials closer to participants and embed themselves in local communities, therefore fostering trust among participants and removing barriers that may have historically prevented diverse or rural populations from enrolling or staying in trials.
Mobile Visits: PCM Trials’ mobile clinicians expand the reach of clinical research by bringing trials directly to patients, delivering the full range of trial activities that can be safely conducted in a mobile setting. For participants who may live far from research centers or face mobility challenges, mobile visits offer the flexibility to engage in trials from the comfort of their homes or other convenient locations, increasing engagement and reducing dropout rates.
Community Research Sites: EmVenio’s community-based research sites complement mobile visits by establishing research facilities within local communities. These sites are staffed by local healthcare professionals and designed to feel like a part of the community, helping participants feel comfortable and supported throughout the research process. Booth noted how community sites also address the “research desert” phenomenon, bringing clinical trials into regions where access to healthcare has historically been limited.
Lessons Learned: Building Diversity Action Plans for Maximum Reach and Retention
The experiences of PCM Trials and EmVenio stress a few essential elements in creating effective DAPs:
- Outline goals from the start. Developing diversity goals should be an early step in trial design, not an afterthought. By identifying potential barriers at the outset, sponsors can proactively address challenges to recruitment and retention, rather than scrambling to adjust mid-study.
- Incorporate participant-centric solutions. Clinical trials are not one-size-fits-all. Offering flexible options—like mobile visits and local community sites—ensures that participants have choices that align with their needs and lifestyles, supporting both recruitment and long-term engagement.
- Leverage strategic partnerships. Collaborating with experienced partners like PCM Trials and EmVenio allows sponsors to tap into proven strategies for reaching underrepresented populations. With over 675 trials supported and operations across 80+ countries, these organizations have a demonstrated commitment to extending the reach of clinical trials.
Expanding Global Diversity Standards
As diversity becomes a priority for regulatory bodies globally, embracing diverse trial designs is crucial for meeting not only FDA standards but also those of other agencies like the EMA and MHRA. By gathering real-world data from diverse participants, sponsors can build a stronger case for product approval across multiple markets.
PCM Trials and EmVenio remain at the forefront of these initiatives, bringing clinical trials to underrepresented populations through innovative, community-focused solutions. By adopting the strategies and insights shared, sponsors can build actionable, effective DAPs that drive inclusivity and improve overall trial outcomes.
At PCM Trials and EmVenio, we are driven by a commitment to participant optionality and expanding the reach of clinical trials — together, we can shape the future of diverse, patient-centered research.
To discuss how PCM Trials can support your clinical development program, please email [email protected].
