Madeline Geday
Merck and Co, Inc.

Mindy Leffler
Casimir

he under-representation of racial and ethnic minority populations in clinical trials remains a long-standing problem. Following the FDA Safety and Innovation Act of 2012, FDA, industry, and others have continued to work to advance diverse inclusion in clinical trials. The DIA Forum on Clinical Trial Diversity: Moving from Admiring the Problem to Solving It convened a multi-stakeholder panel to describe a range of perspectives on practical solutions and strategies for strengthening diversity in clinical trials. The forum included a poll of attendees that revealed views on barriers to diverse enrollment and how best to overcome those barriers.

Key Takeaways

• The FDA’s Office of Minority Health and Health Equity works to raise awareness and advance racial and ethnic minority participation in clinical trials through development of a variety of culturally and linguistically competent strategies and resources.
• Merck is working to close the diversity gap through various tactics and tools that together have helped to advance enrollment and achieve successful inclusive clinical trials.
• Sites are critically important to ensuring diverse enrollment in clinical trials and should develop strategies on how best to reach their community and the populations they are seeking to enroll.
• Many of the barriers to participation can be anticipated and mitigated with an empathetic and substantive listening to patients.

In this session, stakeholders discussed their perspectives from industry, government, site investigators, and patients on the need for diverse participation in clinical trials. The session began with polling audience members to understand their role in clinical trials: 86 percent of the attendees were sponsor staff, 9 percent site staff, and 5 percent represented other areas. When asked about the biggest barrier preventing diverse participation in clinical trials, the audience revealed the following in ranked order: accessibility, inadequate recruitment and retention efforts, awareness/education, lack of trust, other, and data privacy issues. The most help is needed from these stakeholders to make diverse participation a reality in their trials: sites, community influencers, senior management, and regulators, in that order.

There have been many efforts across government, industry, investigator sites, and patient groups to advance diverse inclusion in clinical trials. Regulators have continued to encourage diverse enrollment through legislation and guidance. The FDA’s Office of Minority Health and Health Equity has continued to advance racial and ethnic minority participation in clinical trials through a variety of culturally and linguistically competent strategies and resources, including an ongoing campaign to provide positive reinforcements and raise awareness on the need for racial and ethnic minority populations to participate in clinical trials. This included educational materials in English and Spanish that highlight the value of clinical trial participation; public service announcements and social media outreach that encourage different groups to participate; engaging different communities and health professionals to raise awareness about the need for diverse participation; and developing close collaborations across government, academia and industry to educate consumers and communities about the importance of diverse participation in clinical trials.

From an industry perspective, the FDA’s ongoing efforts, including Drug Trials Snapshots, have increased industry’s attention to advancing diverse participation in clinical trials and solving the problem. For example, Merck is working to close the diversity gap through various tactics and tools that together have helped to advance enrollment and successful inclusive clinical trials through education, culturally sensitive and health literate outreach tools, site selection with diversity as a priority, engaging subject matter experts (including community partners) to build trusted relationships, and continuous monitoring of enrollment. Through these distinct areas, Merck has worked to make diversity a part of their corporate structure by setting programmatic level strategies and objectives with a focus on diversity and on incorporating the patient voice in trial design and recruitment strategies. Merck works with sites to ensure they have the support they need to enroll diverse populations, using geolocator tools, providing resources to accommodate for travel and other reimbursements, and working to ensure that enrollment reflects the diversity of the population most likely to use the product. These efforts have led to success with continued Merck senior leadership and management support.

Sites are critically important to ensuring diverse enrollment in clinical trials. As described by work done at Emerson Clinical Research Institute, sites should consistently connect with the community, build trusted relationships, develop and maintain culturally sensitive and aware communications, and engage with their patients and their patients’ families. Sites should develop strategies on how best to reach their community and the populations they are seeking to enroll. When trying to identify sites, industry should consider sites that have expertise and access to diverse populations and those that have been successful in enrolling and maintaining consistent relationships with populations that reflect diversity. Sponsors should spend time with sites to determine the support they need to enroll diverse populations and ensure the demographics of the site location are reflective in the populations enrolled in their trials. Multilingual staff, flexible hours, transportation assistance, and culturally competent and sensitive site staff all contribute to diverse enrollment in clinical trials.

Patients should always be considered during the clinical trial process—from beginning to end. During the session, we had the privilege of understanding patient perspectives and considerations in clinical trials from a rare disease focus. Key points that are essential to patient enrollment and inclusion were centered around the following themes: