There is a longstanding reluctance among minority populations to participate in clinical trials designed to evaluate therapies for treating disease. From the now-infamous Tuskegee syphilis studies where infected African American men were deliberately left untreated, to the sterilization of many women in Puerto Rico without their informed consent, people of color have learned through bitter experience that their interests and those of the health care establishment may not coincide. “There was a kind of apprehension and kind of fear on the part of our community,” says Rev. Leroy Odinga Perry, DMin, pastor of St. Stephens AME Zion Church in Branford, Conn.
In and near New Haven, a wariness of working with researchers from Yale was a natural consequence, as it has long been in many minority communities located near American research universities. Yale has joined forces with the federal Food and Drug Administration (FDA) to ameliorate that, through a Memorandum of Understanding (MOU) they signed in 2018 to encourage more minority participation in clinical trials.
Among the nation’s medical schools, Yale is especially well positioned to participate, because since 2011 it has worked to engage the local community through its Cultural Ambassadors program. The Ambassadors are leaders from Connecticut’s African Methodist Episcopal (AME) Zion Church—including Perry—and from Junta for Progressive Action, which advocates for Latino/Latina people and provides social services. They have formed an alliance with Yale to convince their constituencies that the trials benefit both those who participate and the wider community. Perry calls it “a link that had been missing between the community and the scientific community.”
According to the FDA, “experience has shown that there can be important differences in how people of diverse groups respond to medical products ... so it is important for patients in those populations who are more likely to be treated for a condition to be included in a trial.” African Americans are known to have disproportionately high rates of diabetes and heart disease, for instance, but unless they participate in trials affecting those conditions, their differing needs may be overlooked before the FDA approves new treatments. “We need to have enough diversity in clinical trials of drugs and devices to ensure therapies are effective in all populations,” says Tesheia H. Johnson, MBA, MHS, deputy director and chief operating officer of the Yale Center for Clinical Investigation (YCCI), which receives substantial support from a National Institutes of Health Clinical and Translational Science Award (CTSA).
Tuskegee and Puerto Rico—and society’s wider racism—made that logic a tough sell for Johnson when she first wanted to create the Ambassadors program, even to her own uncle. The late Rev. Timothy Howard was AME Zion’s presiding elder in the state. Johnson recalls that she told him, “ ‘I need a favor,’ and he said, ‘anything for you,’ and I said, ‘I need your help with clinical research.’ His response was, ‘no way!’ ”
But when Howard and other ministers agreed to at least hear her out, the path forward was established. “Once we realized that we could be part of something great and historic,” recalls Perry, “and that we could be a part of something that’s going to help find cures and could save so many lives, we could not say no to that.” Celina Fernández, a case manager at Junta, and also an Ambassador, says her community needed to overcome a perceived lack of basic respect. “A lot of people say, ‘my doctor mocked me because I couldn’t speak English,’ or ‘my doctor ignored my symptoms. We go into our doctor’s office and are told we don’t matter, yet all of a sudden when it comes to creating research we’re very important?’ ” But Fernández, too, is now firmly on board.
She and the other Cultural Ambassadors meet monthly with leaders from YCCI as well as members of the Yale faculty who design and conduct trials, and take the time at these meetings to explain them. “They give us a wonderful overview of exactly what they’re covering,” says Fernández. “ ‘This is who we are looking for, this is the treatment we are looking at.’ ” From there, an Ambassador might suggest names of suitable participants, or go back to the community and share what the Yale researcher has said. Just as important, they will share with the investigator how certain approaches to potential participants might be ineffective or even offensive for cultural reasons.
Ambassadors, for instance, guided Monica R. Ordway, PhD, APRN, associate professor of nursing, as she designed a study to examine how sleep may be connected to stress among diverse, multi-ethnic toddlers. Ordway says common behavioral sleep interventions for young children were developed by studying mostly middle-to-high-income educated white families, “without consideration of the unique circumstances of those with lower socio-economic status, such as work schedules and shift work, cultural beliefs, crowded housing, issues around light and noise in the neighborhood, and safety.” Ambassadors, she says, provided constructive feedback to her proposal as she and they discussed the state of science regarding sleep and health in early childhood.
They also advised Ordway on how to approach families in terms that would resonate with their lives, such as speaking of sleep deprivation as affecting children’s behavior and school performance rather than more distant concerns such as health risks later in life. “When I think about the success of my program, one of the first things that I think about is that meeting where they talked to me about how I frame this with families.” In turn, when some community members resisted cooperating with her, Ambassadors became her advocates. “Because they had already met with me and vetted my study, they were able to then speak to the quality, and the safety, and express to concerned community members their support of the study,” says Ordway.
Ambassadors’ valuable advice has included hiring diverse clinical trial staffs to whom participants can relate. “Hearing the information from people who look like them, people who sound like them, people who have had similar experiences, is the relief that they need,” says Fernández, “and it creates some of that open-mindedness that’s needed to make these trials really successful.”
Johnson says Yale’s relationship with its Cultural Ambassadors has been invaluable. “Last year Yale hit a record high—30% across all of our clinical research was from underrepresented populations,” she says. And through the MOU, even more is now happening. Cultural Ambassadors are receiving additional training to be certified as community health workers who can recognize early signs of illness among their neighbors and parishioners, discuss their health needs frankly, and connect them with the right resources. Yale has worked to help Duke University establish a Cultural Ambassadors program, and also is building relationships with groups in Puerto Rico and with University College London. And Perry is developing a proposal for Hood Theological Seminary in North Carolina, which trains many future AME Zion pastors, to provide health-related instruction as part of the curriculum.
It marks a major turnaround from Perry’s initial thinking, and Perry credits Johnson. “She has been phenomenal in the sense that she wants to keep this collaborative,” Perry says. “There is no, ‘you must.’ We are able to critically do our own thinking and to participate in these studies as partners. I appreciate that and I think that’s part of our success.”
(l-r) Cultural Ambassadors including Celina Fernández and Rev. Leroy Perry advise Tesheia Johnson of the Yale Center for Clinical Investigation—as well as others from Yale who shape clinical trials—on how best to design, promote, and conduct the trials so that members of minority communities will feel comfortable participating. It is increasingly evident that Inclusion of underrepresented populations in trials enhances their scientific validity and makes it more likely that FDA-approved treatments will meet those populations’ unique needs.