Lack of diversity in clinical trials for Alzheimer’s and other diseases is hurting research, experts say. New data offers some solutions.
New research presented at 2021’s Alzheimer’s Association International Conference sheds light on the reasons that communities of color are underrepresented in clinical trials for Alzheimer’s and related dementias — and possible insights into how to correct course.
In the next nine years, experts say nearly 40 percent of the more than eight million Americans living with Alzheimer’s and related dementias will be Black or Latino, yet they — along with American Indians — are less likely to be included in clinical studies. Researchers are now beginning to understand why these chasms exist, and are working to recruit communities of color in greater numbers.
At the annual Alzheimer’s Association International Conference, researchers have shared new evidence-based insights into why people from traditionally underrepresented communities of color may not participate in clinical trials.
“As we get better at recruiting diverse populations, it will increase the urgency to get the conduct of trials right,” Dorothy Farrar Edwards, the faculty director of the University of Wisconsin Collaborative Center for Health Equity, said in a statement. She also is an investigator and outreach, recruitment, and engagement core leader for the Wisconsin Alzheimer’s Disease Research Center. Farrar Edwards and her colleagues created the Voices Heard Survey to identify factors associated with willingness to participate in biomedical research.
According to the Voices Heard Survey findings, Black, Latino, and American Indians are more likely to volunteer for a clinical trial if asked by someone of the same race; they’re also more concerned with work, family disruptions, availability of transportation, and childcare than their white counterparts.
Other research presented at AAIC has indicated that the criteria typically used for clinical trials — which includes a person’s age, location, other health conditions, and the medications they take — could disproportionately affect Latino and African Americans. Researchers found that 60 percent of the trials assessed on one analysis did indeed have at least one exclusion category that could disproportionately affect Black or Latino populations.
Alexandra Mitchell, clinical research coordinator at the NIA and a researcher in one of the studies presented at AAIC, said in a statement: “This analysis is helping us ask an important question: Can we strengthen our criteria for clinical trials to maximize the number of eligible people from diverse and under-represented communities? We hope the Alzheimer’s community will take a closer look and can mimic the success in the oncology field where a concerted effort resulted in reworded, more equitable exclusion criteria.”
However, the Voices Heard Survey also shed light on some reasons that people of color do participate in clinical trials, paving the way for stronger approaches to diversity recruitment moving forward: The data showed that 85 percent of survey respondents volunteered for a clinical trial when they were invited to participate; 83 percent wanted to contribute to the research goal, and 74 percent had a family member with the disease.
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Of the 406 Wisconsin residents who participated in the 96-item Voices Heard Survey, 100 were white; 105 were African American; 100 were Latino, and 101 were American Indian. They identified some negative factors that would affect their willingness to participate in biomedical studies and clinical trials, which included availability of childcare and transportation, and a disruption to family and work responsibilities.
“African Americans are more likely than the white population to have Alzheimer’s specifically,” Carl V. Hill, the chief diversity, equity, and inclusion officer for the Alzheimer’s Association, said in a phone interview with Being Patient. “We need to assure communities of color that new treatments are safe and effective.”
Hill, who is Black, said he understands the need to identify and remove barriers to entry in Alzheimer’s research. He has a personal history with the progressive disease that affects memory, thinking, and behavior. His paternal grandmother, Effie Hill, died recently at 96, after living with dementia for at least five years. He said someone like his grandmother could have benefitted from diverse clinical trials.
To this end, Hill said, the Alzheimer’s Association has zeroed in on a mission to support innovative ideas around diversity recruitment in clinical trials, particularly recruitment efforts tailored to various communities around the country.
For example, Hill noted the organization is partnering with local African Methodist Episcopal churches and Black Nurses Rock throughout the country to increase the number of Black participants in clinical trials significantly; the National Hispanic Medical Association for more targeted outreach to Latino populations; and the Tzu Chi International Medical Association to ensure Asian communities are represented.
Additionally, Hill said the Alzheimer’s Association also encourages researchers to have satellite locations in specific communities to ease transportation issues.
Researchers and trial administrators are working to clear these obstacles.
This week, the National Institute on Aging, part of the U.S. National Institutes of Health, launched a new online tool called Outreach Pro that will also help researchers and clinicians increase the number of communities of color in clinical trials on Alzheimer’s and other forms of dementia. Outreach Pro currently includes materials in both English and Spanish designed for Black and Latino populations. Plans are underway to include materials in various Asian languages by the Fall of 2021.