The Yale School of Medicine announced a partnership with the U.S. Food and Drug Administration on April 6 to improve diversity in clinical research.

As a long-term, multi-year collaboration, the initiative aims to tackle underrepresentation of minority patients in clinical trials. Historically, most clinical trial subjects have been Caucasian males — with the implicit assumption that results would apply to all genders and races — according to Robert Alpern, the dean of the School of Medicine. Despite the recognition of the importance of including all target populations in clinical trials, it has been difficult to enlist minority patients, he said. To address this challenge, the two institutions will design a range of programs, including trainings, seminars, education and fellowships.

“Our ultimate goal is to have historically underrepresented populations be appropriately represented in clinical research,” said Tesheia Johnson, the chief operating officer of the Yale Center for Clinical Investigation. “This is a huge international issue for research: How do we approach it in an effective way? How do we identify our strategies that really are transferable and adoptable by other places?”

The partnership began initial discussions last October, when the FDA recognized the potential for several of Yale’s clinical research diversity initiatives to be implemented outside of Yale and ultimately benefit a larger number of patients.

After establishing a formalized memorandum of understanding agreement, the two institutions work together more intimately now, according to Johnson. The agreement gives the FDA the latitude to participate with Yale as partners at every level, she explained.

“Captain Richardae Araojo [the FDA’s associate commissioner for minority health] and her team can co-chair committees,” Johnson said. “If we decide to do a seminar series or training, they can participate as speakers or trainers.”

One of the first targets of the collaboration is to build on the success of the Yale Center for Clinical Investigation’s seven-year-old Cultural Ambassadors Program. Funded by the National Institute of Health’s Clinical and Translational Science Award, the program enhances patient recruitment efforts by linking researchers directly to resources in the community.

These resources include representatives from the community organizations Junta for Progressive Action and the African Methodist Episcopal Zion Church. The Cultural Ambassadors advise Yale investigators on how best to raise awareness of clinical research and engage the community.

“The Ambassadors program has been very innovative in addressing the issue of minority recruitment to clinical trials,” Alpern said. “This is a national issue and thus, the FDA is very interested in understanding our approach and extending it nationally.”

To more effectively spread the program’s strategy to other institutions around the world, Johnson said Yale hopes to leverage its connection to the larger network of Clinical and Translational Science Award academic hubs.

For example, Yale will work with Duke University, which has also received the award. Other partnering institutions include the Emerson Clinical Research Institute and the Puerto Rico Consortium for Clinical Investigation.

Another strategy currently under discussion is to provide more training, mentoring and support to health care providers who practice in communities that serve underrepresented populations. This strategy may encourage more participation by patients in these communities, Johnson explained.

Finally, an education and awareness campaign will be designed to reverse the stigma of clinical research, which is particularly prevalent in underrepresented communities.

“We hope that when you say participation in clinical research, the first thought isn’t ‘guinea pig,’ but is: ‘Wow, that’s interesting. I’d love to think about a research opportunity,’” Johnson said.

On May 9, the participating institutions, along with industry sponsors, will attend a conference on diversity in Puerto Rico and further conversations about initial priorities of the collaboration.

Amy Xiong | amy.xiong@yale.edu