Advancing Clinical Trial Diversity Through Community Engagement

s the US population continues to grow increasingly diverse, ensuring appropriate and meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to advancing public health. Racial and ethnic minorities have historically been and continue to be underrepresented in clinical trials and are disproportionately burdened by many chronic and debilitating diseases. Barriers to participation include a lack of trust due to historical abuses. While other barriers may be due to language and cultural differences, religion, trial design, time away from jobs and other commitments, or a lack of awareness and knowledge about what a clinical trial is and what it means to participate, all stand in the way of fuller minority representation in clinical research.

Because clinical trials provide evidence for evaluating whether a medical product is safe and effective, and minority populations may respond differently to certain medical products, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the product so that sub-population data can be appropriately analyzed, and more meaningful clinical data can be communicated to the public.

Protecting and promoting the health of diverse populations is central to the mission of the FDA Office of Minority Health and Health Equity (OMHHE). OMHHE is able to achieve this mission through efforts dedicated to advancing minority health focused research, and outreach and communication that works towards addressing health disparities and achieving health equity. Advancing diverse participation of minority populations in clinical trials is a key priority area for OMHHE. In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA), specifically section 907, emphasized the need for increased racial and ethnic minority participation in clinical trials. In response to FDASIA, OMHHE created the Diversity in Clinical Trials Initiative to raise awareness around minority participation in clinical trials. This initiative consists of an ongoing multi-media campaign to raise awareness on the importance of racial and ethnic minority participation in clinical trials, and includes multiple strategies:

• Educational materials in English and Spanish that highlight the value of clinical trial participation.
• Videos and Public Service Announcements including social media outreach that encourage different groups to participate in clinical trials.
• Ongoing outreach to engage different communities and health professionals to raise awareness about the need for diverse participation in clinical trials.
• Webinars, lectures, and podcasts.
• A dedicated webpage with all resources and materials, including a communications toolkit.
• Collaborations across government, professional associations, community-based organizations, academia, industry, and others to educate consumers and communities about the importance of minority participation in clinical trials..

FDA OMHHE’s Diversity in Clinical Trials Initiative is continuously evolving and new resources and tools are added to advance the goals of the initiative. One goal is to achieve a multisector approach to address this problem through partnerships, engaging patients and providers, and sharing best practices as opportunities to continue to advance racial and ethnic minority participation in clinical trials.

One opportunity to help overcome barriers to diverse participation is consistent and continued community engagement through working with cultural ambassadors, faith-based organizations, and with trusted leaders in the community. To enhance community engagement efforts, the OMHHE developed a Memorandum of Understanding (MOU) with Yale University. A specific area of focus for the MOU is collaborations to cultivate and advance the Yale Cultural Ambassadors Program and the engagement of community partners to increase participation of diverse and historically underrepresented or underserved populations in clinical research. The MOU also forms the basis for the development of scientific collaborations, outreach and educational initiatives, fellowships, and internships.

Yale Center for Clinical Investigation’s Cultural Ambassadors Program was developed in 2009 and formally launched in 2010. Funded by the National Institute of Health’s Clinical and Translational Science Award, the program enhances patient recruitment efforts by linking researchers directly to community resources. These resources include representatives from the community organizations Junta for Progressive Action and the African Methodist Episcopal Zion (AME Zion) Church. Cultural Ambassadors advise Yale investigators on how best to raise awareness of clinical research and engage the community. The Ambassadors Program has been very innovative in working toward addressing issues related to minority recruitment in clinical trials. The Ambassadors work to build trust within the community and provide education and raise awareness of clinical trials and research overall. They receive continuous training and education on areas such as clinical trial design, medical product development process and regulations, and human subject protection, to name a few.

This program has made an incredible local impact. Last year, this program helped Yale recruit more than 26,000 participants to research studies, with underrepresented populations making up 30 percent of all participants in clinical research at Yale.

Yale has already begun work to expand the program, which engages African American leaders from the AME Zion Church and Latino community leaders at Junta for Progressive Action in study design and recruitment. Through this collaboration, Yale and OMHHE plan to build on the program’s model and advance activities to support diverse patient recruitment efforts nationally and globally. These efforts also include developing initiatives to further the education and participation of racial and ethnic minority health professionals in science careers and biomedical research through mentorship programs, training, and promoting scientific workforce opportunities for individuals from underrepresented groups.

Both OMHHE and Yale have strong commitments towards increasing appropriate and meaningful inclusion of racial and ethnic minority populations in clinical trials since a lack of diverse participation impacts the quality of data available to evaluate responses to medical products among minority and underrepresented groups. Engaging the community is one opportunity among a multi-stakeholder approach that helps support clinical trial diversity. OMHHE and Yale aim to continue to amplify and raise awareness on the need for racial and ethnic minority participation in clinical trials and help increase the impact nationwide and globally.