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FDA Office of Minority Health and Health Equity Collaborates With School of Medicine to Promote Clinical Trials Diversity

October 27, 2021

The Food and Drug Administration’s Office of Minority Health and Health Equity (OMHHE) has awarded a $3 million contract to Yale School of Medicine (YSM) to promote clinical trial education, awareness, and access for underrepresented minorities. Yale made great strides in this area at the height of the COVID-19 pandemic, and the work now being funded will build on that work by further refining approaches to building trust and participation in trials in diverse communities across the country.

“Participation by diverse communities is vital to ensuring that people who will ultimately use the medical products are included in the clinical trial to better understand how they will respond to the medical product. Funding this study is another step toward achieving these goals by deepening our stakeholder engagement to help meet the needs of our communities,” said RADM Richardae Araojo, Associate Commissioner for Minority Health at FDA.

The work will be carried out under the direction of Brian R. Smith, MD, deputy dean for clinical and translational research, chair and professor of laboratory medicine, and professor of biomedical engineering, of medicine (hematology), and of pediatrics at Yale School of Medicine; along with John Krystal, MD, Robert L. McNeil Jr. Professor of Translational Research and professor of psychiatry and neuroscience. Smith and Krystal are co-directors of the Yale Center for Clinical Investigation (YCCI). YCCI provides clinical trials infrastructure and is dedicated to improving the health and well-being of individuals and communities by increasing the participation of diverse and historically underrepresented or underserved populations in clinical research. It also looks to address primary health care needs in those communities through programs in education, research, and service, and to increase the diversity of the health professional and scientific workforce.

The newly funded project will focus on understanding factors that contribute to morbidity and mortality in racial and ethnic minority populations, including COVID-19; utilization of real time data and electronic health records (EHR) to provide population health management and access to clinical trials information, including integration of community level social determinants of health information; and understanding ways to amplify linguistically and culturally appropriate information related to COVID-19 research awareness, participation, and retention as well as prevention strategies.

YCCI and OMHHE previously signed a memorandum of understanding in April 2018. Its primary aims include 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. For a decade, this partnership between Yale and the broader community has been driven by representatives from New Haven’s African American and Latino communities. In particular, local leaders of the AME Zion Church, home to the nation's oldest African American congregations, have been stellar collaborators, serving as expert resources and advising Yale investigators on how best to raise awareness of clinical research and engage the community.

“Our aim with this contract is to understand and amplify the perspectives of community leaders, community-based health care providers and organizations, and the general public. We want to become more community-responsive, especially around issues of social determinants of health, participation in clinical trials, and the use of data to drive health decisions,” said Marcella Nunez-Smith, MD, MHS, associate dean for health equity research, C.N.H. Long Professor of Medicine (General Medicine), and professor of epidemiology (chronic disease) and of public health (social and behavioral sciences), who is one of the project investigators.

The Ambassadors participate in projects, community engagement activities, and community events designed to promote and increase participation in clinical trials; assist in the development of recruitment plans for specific trials; and assist in the development of protocols for specific trials. The trust and participation that the Ambassadors have generated in a segment of society with historical reservations about both clinical trials and health care in general are a solid foundation for the new work that the FDA is funding, which will include further developing linguistically and culturally appropriate information for diverse communities.

There is social, psychological, and historical resistance when it comes to minority involvement in medicine in America,” said Rev. Leroy Odinga Perry, DMin, pastor of St. Stephens AME Zion Church in Branford, Conn., and one of the leaders of the Cultural Ambassadors. Perry said, “Much of our work over the past 10 years has been dedicated to addressing the concerns that have caused this resistance.”

The breadth of expertise within Yale and the clinical trial infrastructure the university possesses further solidify Yale’s ability to innovatively meet the goals of the contract, according to Tesheia H. Johnson, MBA, MHS, deputy director and chief operating officer of YCCI, who is also a project leader. “In addition to participation from a broad variety of clinical departments within the School of Medicine,” said Johnson, “we also have important collaboration from our schools of public health and of management, both of which will help us answer some of the broader questions that apply to enhancing public participation in clinical trials.”

In addition to the Cultural Ambassadors, who will continue to engage with their constituents using messaging tools that now will be further refined, available resources will include Yale’s highly sophisticated EHR system, through which patients who may benefit from enrollment in a trial will be informed by their treating providers. This also allows the opportunity to engage providers at a community level in research. Yale’s patient population is a close demographic match with that of the country as a whole, and as the largest patient referral center in southern New England, Yale has a range of clinical specialties that will be a rich source for innovative clinical trials for a broad range of diseases and conditions. Trials incorporate the resources of Yale New Haven Health System as well as those of Yale School of Medicine and its clinical practice, Yale Medicine.

“Although many patients recognize the benefits of participating in clinical research,” comments Brian R. Smith, MD, the study principal investigator, “recruitment remains a major roadblock to the successful completion of a clinical trial. The population of our region, and of the country as a whole, will be healthier if we develop new ways to make trials more accessible to all patients. We are hoping this research will help us find innovative solutions to address the challenge.”

Other project investigators include, Eric Velazquez, MD, Robert W. Berliner Professor of Medicine (Cardiology); Allen Hsiao, MD, professor of pediatrics (emergency medicine) and of emergency medicine; James Dziura, PhD, MPH, professor of emergency medicine, of biostatistics, and of medicine (endocrinology); Yauheni Solad, MD, MHS, associate research scientist (biostatistics) at Yale School of Public Health; Wade Schulz, MD, PhD, assistant professor of laboratory medicine and of biostatistics; Nitu Kashyap, MD, FAMIA, assistant clinical professor of internal medicine; Vineet Kumar, PhD, associate professor of marketing at Yale School of Management; Arjun Venkatesh, MD, MBA, MHS, associate professor of emergency medicine; and Brita Roy, MD, MPH, MHS, assistant professor of medicine (general medicine), and of epidemiology (chronic diseases) at Yale School of Public Health; along with community leaders from both the Yale Cultural Ambassadors program and the Center for Research Engagement (CRE) Steering Committee.

Submitted by Robert Forman on October 26, 2021