Yale collaborates with FDA to advance diversity in clinical research

To promote scientific progress and diversity in clinical research, Yale School of Medicine and the U.S. Food and Drug Administration have agreed to collaborate on a range of far-reaching science-based initiatives. Through trainings, fellowships, internships, research, and education, the agreement will foster the exchange of scientific information between the institutions and improve human health.

“We’re excited about partnering with the FDA on this important initiative. It will enhance our efforts to increase the participation of underrepresented minorities in clinical trials, ultimately broadening our ability to benefit a larger number of patients,” said Robert J. Alpern, M.D., dean of the Yale School of Medicine.

A priority for Yale and the FDA’s Office of Minority Health is the Yale Cultural Ambassadors Program, an initiative that broadens community participation in clinical research by directly linking investigators to community organizations and resources. Together, the institutions will work to further cultivate the program, which was developed with the support of Yale School of Medicine and the NIH-funded Clinical and Translational Science Award. The Ambassadors Program has increased participation of diverse and historically underrepresented or underserved populations in clinical research at Yale and beyond.

“Diverse participation in clinical trials is important to help ensure medical products are safe and effective for all, said Captain Richardae Araojo, associate commissioner for Minority Health at the FDA. “The FDA’s Office of Minority Health engages a broad range of stakeholders in our efforts to increase racial and ethnic minority participation in clinical trials. We are very enthusiastic about this opportunity to collaborate with Yale and contribute to the work they are doing to advance minority health.”

Yale has already begun work to expand the seven-year-old program, which engages African American leaders from the African Methodist Episcopal Zion Church and Latino community leaders at Junta for Progressive Action in study design and recruitment. Through the collaboration, Yale and the FDA plan to build on the program’s successful model and advance diverse patient recruitment efforts nationally and globally. In addition to the local Connecticut-based community leaders, Yale is working with the Duke University CTSA, Emerson Clinical Research Institute, and the Puerto Rico Consortium for Clinical Investigation.

Yale and the FDA will also develop initiatives to further the education and participation of a diversity of health professionals in science careers and biomedical research. Activities will include mentorship programs, research training, and the promotion of scientific workforce opportunities for individuals from underrepresented groups.