Yale’s Decade-long Effort to Increase Diversity in Clinical Trials

The participation of minority groups in clinical trials is an ongoing challenge that was underscored during the COVID-19 pandemic: Black individuals represented 21% of COVID-19 deaths, yet they comprised just 3% of major vaccine trial participants. Other minority groups were also underrepresented.

For over a decade, the Yale Center for Clinical Investigation (YCCI) has spearheaded efforts to change the landscape of diversity in clinical trials. YCCI provides infrastructure and training to support clinical research and works to improve the health of all individuals and communities by increasing participation of marginalized population in clinical research.

In 2010, YCCI established the Cultural Ambassadors program to ensure that clinical trial participation reflects the diversity of New Haven’s population, which is 34% Black or African American and 31% Hispanic or Latino. YCCI partnered with Junta for Progressive Action and the African Methodist Episcopal Zion (AME Zion) Church to create this bi-directional program. YCCI provides intensive training with Yale School of Medicine researchers on such topics as the importance of clinical research, how it is conducted, and protections for human subjects, while Cultural Ambassadors act as expert resources, advising Yale investigators on how best to engage their communities in clinical research.

In New Haven, the Cultural Ambassadors program—along with direct-to-patient recruitment via Yale’s electronic health record and other initiatives—has had a significant impact on the diversity of clinical trials: people of color now represent about 30% of participants at Yale.

The influence of the Cultural Ambassadors was particularly evident in the early stages of the COVID-19 pandemic. Cultural ambassadors were active in vaccine outreach to their communities and enthusiastically participated in vaccine trials. “When the COVID-19 vaccine trial arrived at Yale, I was compelled to participate. It was a consummate opportunity to sign up and walk the walk, particularly during a time of so much fear and apprehension,” said Rev. Dr. Leroy O. Perry, who has been a cultural ambassador since the program was created. United States Senator Richard Blumenthal (D-CT) praised Yale’s efforts to ensure that communities of color have equal access to both the vaccine development process and the ultimate distribution of vaccines.

Yale has built on the success of the Cultural Ambassadors program by expanding it to Duke University. Both institutions are recipients of the National Institutes of Health Clinical and Translational Science Award (CTSA), which is designed to accelerate the translation of scientific discoveries into practice to improve health. In conjunction with YCCI, Yale Cultural Ambassadors worked with Duke and AME Zion representatives to implement the program in North Carolina.

Yale has also joined forces with the federal Food and Drug Administration’s Office of Minority Health and Health Equity (OMHHE) to increase diversity in clinical trials. In 2018, Yale and the FDA signed a Memorandum of Understanding (MOU) to encourage more minority participation in clinical trials. Initiatives under the MOU include engaging the Cultural Ambassadors program and community partners to increase participation of diverse and historically underrepresented or underserved populations in clinical research; advancing education and participation of diverse health professionals and scientists; and supporting the education and matriculation of diverse students into the health and biomedical science workforce.

In 2021, OMHHE awarded a $3 million contract to Yale School of Medicine to promote clinical trial education, awareness, and access for underrepresented minorities. The project is focused on understanding factors that affect the health of racial and ethnic minority populations, utilizing real time data and electronic health records to access clinical trials, and understanding ways to amplify culturally appropriate information related to COVID-19 research awareness and participation. Faculty from clinical departments from across Yale School of Medicine, as well as from the School of Public Health and Yale School of Management, are collaborating on the project.

“Yale is committed to improving the health of communities of color in New Haven and across the nation,” said Brian R. Smith, MD, deputy dean of research (clinical and translational) and co-director of YCCI. “Ensuring that people of color have access to and participate in clinical trials is an important step in reaching this goal.”