November 26, 2018
Left to right: Jovonni R. Spinner, Senior Public Health Advisor, FDA Office of Minority Health; RADM Denise Hinton, Chief Scientist, FDA; CAPT Richardae Araojo, Associate Commissioner for Minority Health, FDA.
Our country and our community are increasingly diverse, yet ensuring that clinical trials reflect this diversity is an ongoing challenge. The Yale Center for Clinical Investigation (YCCI), is addressing this by forging partnerships to increase the enrollment of diverse and historically underrepresented or underserved populations that are proving to be effective and serving as a model for other institutions.
Most recently, YCCI spearheaded an agreement with the Food and Drug Administration (FDA) that leverages its Cultural Ambassadors program, an ongoing collaboration with Junta for Progressive Action and the Connecticut African Methodist Episcopal Zion (AME Zion) Churches. In this bi-directional initiative, Cultural Ambassadors receive in-depth training on how clinical research is conducted and its role in developing therapeutic advances, while also serving as expert resources on how to engage their communities in clinical trials. Over the past two years, every study in which Cultural Ambassadors have been engaged has had minority participation ranging from 22 to 89 percent (with one exception, which had 12 percent) and more than 6,000 members of minority groups have expressed interest in research studies since the partnership began. In fact, last year, historically underrepresented populations made up 27 percent of all participants in clinical research at Yale.
This approach is of particular interest to the FDA because it can be adopted by other institutions, as evidenced by a newly established collaboration between YCCI, administrative home of Yale’s National Institutes of Health Clinical and Translational Science Award (CTSA) and Duke University’s Clinical & Translational Science Institute, administrative home of Duke’s CTSA. The two organizations have been working with AME Zion representatives to implement the program in North Carolina. The Duke Cultural Ambassadors’ training culminated in a visit to New Haven at the end of June to experience how the program works firsthand during sessions with John Krystal, MD, chair of the Department of Psychiatry, and Eric J. Velazquez, MD, chief of cardiovascular medicine.
Last month, YCCI hosted an Innovation and Diversity Summit to highlight the FDA partnership. Rear Admiral Denise Hinton, chief scientist at the FDA, and Captain Richardae Araojo, the FDA’s associate commissioner for minority health spoke at the summit, along with several YSM faculty members. For many, the high point of the day was hearing from relatives of Henrietta Lacks, an African American woman whose cancer cells are the source of the HeLa cell line. Lacks died of cervical cancer at Johns Hopkins Hospital in 1951, but her family was unaware that her cells were used in research that has led to many medical advances until decades later, when they were contacted about a book on the subject. Today, Lacks’ great granddaughter is a registered nurse who is a strong advocate for clinical research. Her participation at the summit, along with Lacks’ daughter-in-law and other speakers and panelists, underscores the importance of educating and engaging diverse populations in medical research.
The FDA partnership also paves the way for initiatives to further the education and participation of underrepresented minorities in science careers and biomedical research through mentorship programs, research training, internships at the FDA, and the promotion of scientific workforce opportunities.
These efforts are helping to ensure that the School of Medicine delivers on its commitment to broaden access to pioneering research and high-quality clinical care that will benefit all the members of our community.