When Dr. Daniela Pimentel Maldonado, a first-year neuroimmunology fellow at the School of Medicine, began her career in neurological research, clinical trials prioritizing the recruitment of underrepresented individuals in cognitive research were few and far between.
In an interview with The News-Letter, Pimentel Maldonado shared her early experience investigating disease-related cognitive decline at the University of Massachusetts. She described how many trials could only recruit participants who spoke English despite cognitive decline from conditions like diabetes disproportionately affecting Hispanic individuals.
Such barriers, Pimentel Maldonado noted, are not purposeful. Indeed, she said, researchers have good intentions, but oversights can lead to unintentionally restricting diversity in clinical trials.
“If you’re offering a cognitive test in English, and a participant does not speak English, you are unlikely to obtain the same outcome through a translator,” Pimentel Maldonado said. “This is unfortunately how these trials are designed sometimes, and they limit minority enrollment.”
Restraints like these have resulted in the underrepresentation of minorities in clinical trials, including in multiple sclerosis (MS) research. MS is an autoimmune disorder that impacts the central nervous system. While MS predominantly affects whites of European ancestry, it is believed to manifest more severely in Hispanic Americans and African Americans.
Little is known about MS risk, presentation, progression and treatment responses in ethnic and racial minorities since minority groups are underrepresented in MS clinical research. Disparities in resources and education, as well as racial and ethnic discrimination, are thought to be responsible for this underrepresentation.
Organizations like the MS Minority Research Engagement Partnership Network (MREPN) — which is composed of clinicians, researchers and patient advocates — are studying how to increase research engagement in underrepresented communities.
In a recent study published in the International Journal of MS Care, Pimentel Maldonado collaborated with MREPN to investigate attitudes of members of minority groups toward MS clinical research.
Pimentel Maldonado and her team administered a web-based survey assessing research impressions, concerns and preferences of MS patients from three racial and ethnic groups. The survey was available in English and Spanish.
The survey was disseminated by members within MREPN and affiliated organizations. But disseminating the survey was not easy, Pimentel Maldonado said.
“We wanted to recruit as many participants as possible, and we wanted to recruit minority patients in particular,” she said. “But in order to recruit many participants, we had to sacrifice a bit of study generalizability.”
According to Pimentel Maldonado, recruiting patients involved with organizations like MREPN may bias the sample toward patients who are wealthier, more educated and have access to resources like internet connectivity. Reaching members of racial and ethnic minorities remained a challenge.
The challenge was reflected in the racial and ethnic makeup of the study’s 2,599 participants. Non-Hispanic white individuals comprised 81% of the participant pool, while African American and Hispanic individuals comprised only 8% and 7%, respectively.
However, according to Pimentel Maldonado, alternative research methods would have presented similar challenges. Even if the team had recruited participants from MS clinics, she said, the participant pool would have likely still been constrained because racial and ethnic minorities are less likely to be treated in tertiary centers.
“Many minorities are seen in community-based scenarios due to limited insurance coverage, due to the areas where they live,” she said. “It’s complicated, and it’s unclear to say whether we would have had a greater representation of minorities if we had altered our recruitment methods.”
The study collected data on different facets of participant views toward MS research, including concerns about participation, preferred study attributes and trusted sources of information.
While participants generally held a positive attitude toward MS research, the researchers found that minority groups had greater concerns about potential downsides stemming from research participation.
Concerns about privacy violations, risks to employment and legal status and disruptions to medical care were more prevalent among African American and Hispanic participants than non-Hispanic white participants.
The publication advises researchers and clinicians to approach distrust toward clinical research by providing clear guidelines and terms of participation. Investigators should explain what patients should expect from their participation and the risks associated with participation as well as the protections that are provided to maintain patients’ rights, privacy and well-being. Accelerated Cure Project has created a toolkit to help researchers and community organizers make MS research more accessible for minorities.
According to Pimentel Maldonado, participants who know their rights and are equipped with the resources to advocate for themselves are more comfortable engaging with research trials.
“More than anything, [researchers] want affected minorities to know that we want to include them... that we want all the disease interventions we develop to also be available to them and that we want to support their clinicians in developing personalized care plans for them,” she said.
The study also found that minority participants, especially African American individuals, were more likely to rely on community-based sources for information about MS, including religious centers, community leaders and affected individuals within their own communities.
“If a certain group relies on church and community leaders for information about MS... then it is crucial to engage these sources and provide them with sound scientific information,” she said.
Pimentel Maldonado believes that the outlook for increased minority research engagement is promising, given the strong initiatives to include minorities in COVID-19 vaccine trials.
She commended biotechnology company Moderna, one of the two manufacturers authorized to administer COVID-19 vaccines, for slowing down vaccine trial recruitment in October 2020 after failing to enroll enough minority participants, even at the cost of delaying vaccine development.
“This is the first time we’ve seen this kind of large-scale emphasis on minority engagement in vaccine trials,” Pimentel Maldonado stated. “Because everyone is paying attention to these trials, there really is no better opportunity to emphasize the importance of [these initiatives].”