FDA and the School of Medicine collaborate to promote diversity in clinical trials
The FDA Office of Minority Health and Health Equity awarded the Yale School of Medicine a $3 million contract to promote diversity in clinical trials.
Yale Daily News
The School of Medicine was awarded a $3 million contract by the Food and Drug Administration’s Office of Minority Health and Health Equity to promote clinical trial education, awareness and access for underrepresented minorities.
At the height of the COVID-19 pandemic, a School of Medicine study found that participation in clinical trials by diverse communities was integral to developing useful medicines that meet the needs of the entire community. This work built a foundation for more inclusivity in trials, which will be developed and strengthened with the $3 million FDA-issued contract. The new focus will be on further refining ways to build trust and encourage participation in trials in diverse communities across the country.
“Diverse participation is critical in clinical trials,” said Brian Smith, deputy dean for clinical and translational research at the School of Medicine. “Not only do we want to ensure the participant population reflects the diversity of the population impacted by the disease, but diverse participation is critical to understanding any potential differences in adverse effects and/or the effectiveness of potential therapies prior to approval.”
Along with Smith, Yale Center for Clinical Investigation Chief Operating Officer and Deputy Director Tesheia H. Johnson, translational research, psychiatry and neuroscience professor John Krystal and Associate Dean for Health Equity Research Marcella Nunez-Smith are also lead project investigators.
In an email to the News, Johnson detailed how the project will focus on “understanding factors that contribute to morbidity and mortality in racial and ethnic minority populations.”
According to Johnson, the project will also focus on the utilization of real time data and electronic health records, or EHR, to provide population health management and access to clinical trials information. This includes integration of community level social determinants of health information. Additionally, it will focus on understanding ways to amplify linguistically and culturally appropriate information related to COVID-19 research awareness, prevention strategies and participation and retention.
The project has been split into three teams across the medical school to more effectively address key areas of focus in improving diversity in clinical trials.
The first team, led by Nunez-Smith and her team at the Equity Research and Innovation Center, or ERIC, focuses on understanding factors or the combination of factors that contribute to COVID-19 morbidity and mortality in minority populations.
“My team and I will also focus on understanding patient and community perspectives and needs for Social Determinants of Health data collection, use, and sharing,” Nunez-Smith wrote in an email. “We are considering these key questions: What do we know about these issues? How do we know this? What can we do individually and collectively about what we know?”
The second team, led by Johnson, Allen Hsiao, Nitu Kashyap, Yauheni Solad and Wade Schulz, in collaboration with the Yale Cultural Ambassadors, focuses on the utilization of real-time data and EHR data to provide population health management and access to clinical trials information, including integration of community level strategies.
The third team, led by assistant professor of medicine Brita Roy, associate professor Arjun Venkatesh, Vineet Kumar and Johnson, in collaboration with the Yale Cultural Ambassadors, focuses on understanding ways to amplify linguistically and culturally appropriate information related to research awareness, participation and retention for COVID-19 research studies as well as other diseases that disproportionately impact people of color.
“In this [team], we will evaluate the differential impacts of message content and context as well the credibility of the source in driving outcomes along the user journey, including assessing how social media influences can amplify linguistically and culturally appropriate information,” Johnson wrote in an email to the News.
The project analysis will be supported by the team at ERIC and the team at the Yale School of Public Health led by Lisa Calvocoressi, James Dziura and Denise Esserman.
Johnson, Smith and Nunez-Smith collectively emphasised that they hope that the lessons learned will not only improve health outcomes and clinical trials awareness and access in Connecticut, but also be disseminated broadly in future collaborations with the FDA Office of Minority Health and Health Equity and others.
“We strongly feel that it is only with us all working together as equal partners, meeting our community where they are in their information, clinical trials consideration, and health journey, will we be successful in ensuring that everyone has access to innovative clinical trials opportunities as a component of outstanding clinical care,” Johnson wrote.
The FDA Office of Minority Health and Health Equity was founded in 2010.