AMETHIST@Penn Implementation Science Center Headed by LDI Senior Fellows
Increasing the Diversity of Clinical Research Participants
Building Trust is Key to Recruiting Underrepresented Groups
PRIMA. Spanish for “cousin,” this acronym turned out to be the perfect acronym for a qualitative study on the perinatal experiences of Hispanic immigrants in Philadelphia and Kennett Square, Pennsylvania, many of whom work in the region’s mushroom farms. Conjured up during a meeting of the multiethnic, multilingual team that was composing questions for the research, the word prima “engenders trust,” said LDI Senior Fellow Diana Montoya-Williams. “People trust their cousins.”
Building trust is key to engaging minority community members in medical research, in which Hispanic people (especially immigrants), Black people, and other historically marginalized people are critically underrepresented. “Low Latine representation in perinatal and infant health research is especially striking,” said Montoya-Williams, co-author of a recent commentary in Health Services Research called “Overcoming Barriers to the Recruitment of Immigrant Hispanic People in Perinatal Research.” Montoya-Williams and others prefer the term “Latine” over “Hispanic.”
Work by Montoya-Williams and Perelman School of Medicine colleagues–Senior LDI Fellows Carmen Guerra, Professor in the Department of Medicine and Vice Chair of Diversity and Inclusion, and Samuel Takvorian, Assistant Professor in the Division of Hematology and Oncology–show that researchers can succeed at recruiting diverse subjects by dealing directly with several obstacles, such as language differences, distrust of mainstream institutions, and finances. Strategies for researchers include hiring research staff fluent in participants’ languages, using community institutions to recruit subjects, and leveraging Medicaid to pay participants’ expenses.
A Safe Space for Immigrant Mothers to Share Their Experiences
The PRIMA study drew on the principles of community-engaged research, which was defined by the Centers for Disease Control and Prevention (CDC) in 1997 “as a way to improve population health by building and bolstering relationships between researchers and the communities they are researching,” according to Montoya-Williams’ article.
Montoya-Williams explained, “Researchers should be aware of how they are showing up in communities and take care not to appear as an institution coming in to collect data. They should work to develop connections and relationships that benefit those living in the area.” To that end, the study group recruited research staffers who represented local community groups, as well as those who identified as Latine, mothers, or both. “Our research team included people who are immigrants,” said Montoya-Williams.
The power differential between researchers and participants is reduced when they share the same language and country of origin. In the places studied, “it was easy to find research coordinators who speak Spanish,” Montoya-Williams recalled. “But we had to confirm their fluency through testing because many people don’t communicate as well as they think they do.”
A Trauma-Informed Interview Guide
The team avoided questions that might trigger traumatic memories such as migration journeys or dealing with being undocumented in the U.S. Participants were never questioned about their documentation status. Questions were open-ended so that the 24 participants had plenty of time to relate their histories. “We wanted women to feel in control of the story,” said Montoya-Williams.
PRIMA reached its aim of “uplifting stories that are not usually heard,” Montoya-Williams said. It’s too soon to tell if the concrete strategies that came out of the research will achieve the project’s ultimate goal: “to increase Latine immigrant birthing people’s utilization of and comfort with perinatal medical and social services,” according to Montoya-Williams.
Health Care First, Then Research, for Black Cancer Patients
Over a decade ago, Guerra started speaking with community leaders about increasing Black patient representation in clinical cancer trials. “I went there with my agenda because I thought it was the just thing to do,” she recalled. Guerra soon discovered that research was not at the top of the list for community leaders. “One pastor said to me, ‘We don’t care about clinical trials. We care about our brothers and sisters dying of cancer.’”
Confronted with what she calls “a lesson in cultural humility,” Guerra and others spent the next few years working on what community members felt was the more pressing need: identifying individuals with cancer when the disease is more treatable. The team brought programs to Abramson Cancer Center (ACC) that overcame transportation, language, and other barriers, and provided colon cancer screening and mammograms for both under-insured and uninsured people. Once Guerra’s group had accomplished that, “I could pull my agenda back out. Having built trust with faith-based leaders, we could now talk about clinical trials,” she said.
Alongside these programs, Guerra and the Lazarex Cancer Foundation established the Improving Patient Access to Cancer Clinical Trials Program at ACC, which reimburses participants and a caretaker for burdensome costs related to participating in clinical trials.
Guerra learned that Black patients were underrepresented in clinical cancer trials at Abramson. In 2014, Black patients in the 12-county catchment area comprised 16.5% of cancer cases, but only 11.1% of the center’s patients. A concerted attempt to improve those numbers proved highly successful. Abramson’s five-year outreach program reached over 10,000 people at churches, community centers, health centers, wellness fairs, and other Black-oriented spaces. By 2018, the number of Black participants in the center’s clinical trials increased from 1.7 to 4-fold, depending on the type of trial.
Addressing Obstacles at the Provider Level
Recently, Guerra and colleagues, in conjunction with the American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC), have worked on improving barriers to inclusivity among providers. The group developed unconscious bias training for researchers to make it more likely that they offer clinical trials to all eligible participants. In addition, the group created a site self-assessment so that researchers can look at their data on racial and ethnic participants. “ASCO provides resources to address the situation,” Guerra said.
Policy Changes to Improve Access
“Medicaid disproportionately covers patient populations that have historically been underrepresented in cancer clinical trials,” said Takvorian. Policy changes at the state and federal levels may address these inequities and potentially carry a big impact.
In one welcome change, since January 2022, state Medicaid programs have been required to cover routine costs associated with clinical trial participation, including direct costs such as fees associated with hospital stays and doctor visits, and indirect costs such as travel, lodging, and lost wages. This requirement had already existed for Medicare patients and the commercially insured.
Still, “we are hearing that this has been variably implemented by state Medicaid programs,” Takvorian said. Problems include a lack of clear guidance from federal policymakers on the full scope of the benefit and how it should be structured, according to Takvorian. Nonetheless, a preliminary study by his group found a significant increase in Black patient enrollment in cancer clinical trials in the first year of the mandate, among states that had implemented a mandate prior to this new legislation.
To further increase participation, Takvorian also recommends that Medicaid reimburse patient navigators in doctors’ offices to help enroll people in cancer clinical trials and guide them through the process. “The normal treatment process is complicated enough, but with clinical trials patients undergo extra visits, lab work, and imaging. Linking patients with a navigator is another support that could be put in place to level the playing field,” Takvorian said.
An additional improvement would be to ease up on eligibility requirements. “These requirements are often overly restrictive because researchers want pure, uncomplicated cases that will make study results scientifically sound. But this comes at the cost of a study sample that is broadly representative of the whole population standing to benefit from therapeutic advances,” noted Takvorian.
The Federal Drug Administration (FDA) has also moved to increase diversity in late-stage clinical drug trials by requiring pharma companies to submit plans for increasing inclusion in their studies. A rule to that effect is now in the public comment phase.
In the end, says Montoya-Williams, the point of medical research is to “improve the way we deliver health care. If research is restricted to a certain segment of the population, then we are failing to improve the health of all people in society.”
The commentary, Overcoming Barriers to the Recruitment of Immigrant Hispanic People in Perinatal Research, was published in Health Services Research on January 4th, 2023. Authors are Alicia Laguna-Torres, Leo Velosa, Alejandra Barreto, Scott A. Lorch, Senbagam Virudachalam, Diana Montoya-Williams.
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