In 2011, the National Institutes of Health urged all university clinical research centers to increase minority recruitment for medical trials. In response, the Yale Center for Clinical Investigation developed the Cultural Ambassadors program, an initiative that “had potential to bend the curve,” or, in other words, to change the way in which minorities engage with clinical studies. Cultural Ambassadors superseded the Clinical Scholars program, which promoted community-engaged work until it lost funding in 2015. The four remaining sites of this program, which were located at Yale; the University of California, Los Angeles; the University of Michigan; and the University of Pennsylvania, then came together to become the National Clinician Scholars Program, which includes doctors and nurses who have doctorates in nursing. Through Cultural Ambassadors, the rate of minority participation increased to 10 percent in Yale clinical studies — triple what it was before.
The Cultural Ambassadors program aims to create a holistic partnership between the Yale Center for Clinical Investigation and two New Haven nonprofit organizations: Junta for Progressive Action and the African Methodist Episcopal Zion Church, or AME Zion, which serve Latino and African-American communities, respectively. This partnership advocates “clinical trial participation [that] reflects the diversity of New Haven’s population and will benefit patients in the community and beyond,” according to the Cultural Ambassadors website.
Yale was one of the first universities to consider minority recruitment in clinical studies as a major objective. Dr. Margaret Grey, director of the Community Research Core of the Program and deputy director of the Yale Center for Clinical Investigation, said that in her 28 years at Yale, she has seen an incredible level of distrust of medical researchers by minority communities. Despite efforts toward greater minority inclusion in clinical trials, the historically antagonistic relationship between medical researchers and minorities lingers. The crux of the issue, Grey said, is that “minorities are afraid to be in the trials.” Grey emphasized that medical researchers should attempt to cultivate awareness about the lives of minority participants: “We’re taking their blood,” she said. “It’s critically important to create a two-way street.”
The underlying goal of Cultural Ambassadors is to work toward bridging the gap between Yale and New Haven. Grey said that this goal is founded on the belief that dismissing marginalized communities jeopardizes the integrity of research results.
Every month, in a conference room at the Yale Center for Clinical Investigation, researchers meet with leaders of Junta for Progressive Action and AME Zion for two hours to present plans for recruiting more minorities for clinical research. At these gatherings, investigators solicit ambassadors’ input on new research ideas and ask for recruiting assistance. Ambassadors advise on every aspect of the study while also learning about health problems that affect their communities.
Certain diseases disproportionately affect minority communities; diversifying clinical trials aims to collect more relevant, accurate data on conditions such as sickle cell anemia, which is much more prevalent in African-American communities.
Despite these efforts to apply clinical trials to study diseases more prevalent in minority communities, the relationship of minorities to clinical trials at Yale is still fraught. Including more minorities in medical trials cannot single-handedly remedy the broader historical erasure of minorities within the medical sphere, Grey acknowledged.
A yellow building sits on Grand Avenue in New Haven, shrubs and flowers outlining the shape of its structure. A sign at the entrance reads, “Junta for Progressive Action,” with a large and winding J. Inside, children and their families are reading, talking and running around.
Natalia Xiomara is the director of Junta for Progressive Action, a child-based nonprofit that aims to bring the Latino community of New Haven together through educational and economic support. Xiomara said the overall impact of minority inclusion efforts in clinical studies has been positive. Yet she noted that contact between Yale researchers and minority participants in clinical studies sometimes ended after the trials.
One interruption between these two communities is language itself. The language barrier between Yale researchers and the Latino community necessitates the presence of Spanish to English translators. To meet this need, Junta for Progressive Action prioritizes translation services within the organization; all of Junta for Progressive Action’s forms and documents are written in both languages. Members of Junta for Progressive Action have expressed frustration with the medical community because researchers do not always consider the linguistic and cultural needs of minorities in their trials. “We need to be raising awareness in a very particular way,” Grey said. “We need to pay attention to [minorities’] needs.”
Dr. Larry Davidson, a professor of psychiatry and the director of the Yale Program for Recovery and Community Health at the Yale School of Medicine, said that he has seen progress in bridging the gap between medical and minority communities in the last 20 years. Davidson’s research focuses on processes of recovery from serious mental illnesses and the implementation of policies and interventions in systems of care. Davidson echoed Grey, saying that the complications he has noticed within his research and the local mental health care system stem from a lack of attention on the part of medical researchers to the specific needs of minorities in New Haven. Progress “involves making mental health services accessible, understandable and more appealing to minority communities. We need to understand minorities’ life contexts and make our approaches less biomedical and more culturally and linguistically aware to human complexity — albeit within an under-resourced health care system,” Davidson said.
To work toward truly closing the gap between minority and medical communities in New Haven, Xiomara said, a prolonged effort to extend the conversation between Yale and New Haven beyond medical trials is necessary — otherwise, many minorities might end up feeling that they have been reduced to statistics. Examples of these efforts include a follow-up meeting with participants in a cardiovascular study. At the meeting, which was jointly conducted by the Yale Center for Clinical Investigation and Junta for Progressive Action, people shared their family histories with heart trouble. Xiomara said that the meeting helped her see more clearly how these issues affect personal lives beyond the lab.
Grey said that many participants want to know outcomes after the completion of a study. The Cultural Ambassadors program tries to provide a time frame for when participants will hear back from a study. Cultural Ambassadors also holds informational workshops with participants in the trials to inform them about the research they are participating in. Still, according to Grey, the Yale Center for Clinical Investigation could work toward making this information more accessible. Kathryn Dudley, a professor of anthropology at Yale, said clinical trials can be effective only if researchers educate minorities about what they are participating in and what the value is to them. “Otherwise, we’re not measuring whether the organizations’ desires are being met,” Dudley said. “It becomes just another form of exploitation.”
One issue that greatly impacts the overall health of minority communities in New Haven — and that clinical research attempts to address — is mental health. Junta for Progressive Action frequently sees individuals with post-traumatic stress disorder or other trauma-related disorders, many of them from the Puerto Rican community, which is recovering from last fall’s Hurricane Maria — a hurricane regarded as the worst recorded natural disaster in the region. Once Junta for Progressive Action receives individuals struggling with mental health, they are often transferred to the Clifford Beers Clinic in New Haven.
One difficulty with addressing medical and mental health concerns in minority communities in New Haven is that participation in clinical trials often feels inaccessible. Many who join Junta for Progressive Action or AME Zion are simply trying to adjust to their surroundings. Some might even be homeless and must attend to basic human needs before they can even confront the trauma they have experienced, Xiomara said. The opportunity to participate in a clinical study with the Yale Center for Clinical Investigation therefore seems unobtainable to many minorities. “It’s a long way to them saying that they need help,” Xiomara said.
Many members of Junta for Progressive Action who have been displaced from their homes and are seeking mental health treatment go to Clifford Beers Clinic in New Haven, a children’s mental health clinic that has operated for over 20 years. The clinic services around 5,500 children and their families per year. Sixty percent of those served are New Haven residents, one-third are Caucasian, one-third are African-American and one-third are Hispanic, according to Christine Montgomery, vice president of Clinical and Community Based Services at Clifford Beers. In addition, a third of the families speak only Spanish, so translators are often consulted.
Some families say that they are not interested in being guinea pigs for mental health clinical research, according to Montgomery. “There’s some hesitation for the populations that we serve to participate in clinical studies,” Montgomery said. “Many of our kids’ families have been involved in trauma, and they want to reinstate some kind of control in their lives, so participating in a clinical study is scary,” she said. Many patients at Clifford Beers, Montgomery said, are more concerned with day-to-day living than participating in clinical studies. The individuals that Montgomery encounters are often “so disenfranchised, so disempowered,” she said, and some lack access to basic health care. Some older patients remember past abuses with nonconsensual studies, recalling them as part of racist medical practices from 50 or 60 years ago. For others, social stigma around mental health issues makes getting help even more difficult.
Although programs such as Cultural Ambassadors recognize the importance of providing accessible systems of mental health care to minority communities, according to Davidson, it is “too early to tell what the impact [of clinical studies] will be.” There is still a deep and long-standing mistrust between ethnic minority communities and research communities. A challenge of mental health studies, Davidson explained, is that it is difficult for many people to distinguish between clinical disorders and sadness caused by life events, such as losing a spouse. Clinical studies sometimes narrow complex mental health issues to a list of symptoms. Within this framework, he said, “It’s hard for people to understand that depression is more than a serotonin deficiency.”
Relying on drug trials to treat mental health disorders may contribute to a reductive view of mental health. The diagnostic system of identifying mental health issues does not capture the relationship between mental health and socioeconomic and personal factors in many participants’ lives, Davidson explained. Dudley emphasized that there are many questions one could consider with mental health in minority communities. For example, she said, one should situate mental health concerns in the broader terrain of socioeconomic status.
“Regardless of the populations involved, the pharmaceutical ways in which mental health issues are treated are already shot through with gendered, class-based assumptions,” Dudley said. If these studies are attempting to address mental health in minority communities, Dudley feels the approach should be more direct. “To really address mental health concerns in New Haven’s minority communities, what’s required is the interest of mental health professionals in the distinct problems of people’s lives,” she said.
Dudley said the field should resist “the medicalization of social trauma.” If medical researchers do not take the time to learn about the particular circumstances of minority participants’ lives beyond the scope of their clinical trials, Dudley said, “A pill is not going to address the deeply ingrained forms of social injustice that the system has produced.”
As Dudley explained, a universalized pill cannot capture the specific struggles of participants’ lives. To this end, programs such as Cultural Ambassadors aim to recognize the diversity of individual background and experiences. The difficulty, however, is in directly connecting: “Because there have to be middle-men between Yale and the folks they’re trying to engage,” Xiomara said, the clinical study approach often just doesn’t work.