Research Community Seeks to Enroll More Minorities in Clinical Trials
Pandemic puts more focus on disparities
By Melinda Young
Several months of data from the COVID-19 pandemic showed that African Americans and other people of color (POC) were disproportionately dying from the disease. As the crisis continued into the summer, George Floyd was suffocated by a police officer in Minneapolis. Hundreds of thousands of people across the world took the streets in protest.
Both events highlighted the need for systemic societal reform. This includes examining how underrepresented minorities are treated by the healthcare industry and in clinical trials.
“We need equity in health in this country. We must eliminate all the contributing factors to poor outcomes,” said Edith Mitchell, MD, director of the Center to Eliminate Cancer Disparities, Jefferson Hospital clinical professor of medicine and medical oncology, and a past president of the National Medical Association. Mitchell spoke at a WIRB-Copernicus Group (WCG) web conference on June 3.
“COVID-19 disproportionately affects people of color in the United States,” Mitchell explained. “Can we use the awareness of the disproportionate impact of COVID-19 and the need for research representation to bring awareness to the larger issue of ensuring diversity in all clinical research?”
Disparities in how COVID-19 affects minority communities highlight long-standing difficulties in achieving health equity in U.S. society, said Damani A. Piggott, MD, PhD, an assistant dean for graduate biomedical education and graduate student diversity and an assistant professor of medicine at Johns Hopkins School of Medicine. Piggott spoke at the Infectious Diseases Society of America’s May 15 web conference.
Multiple Factors Add to Disparities
Contributing factors to the disparity include other diseases that affect African Americans disproportionately, such as hypertension, kidney disease, heart disease, and diabetes. Other factors relate to disparities in income, employment, housing, educational opportunities, transportation, and incarceration, Piggott noted.
“For IRBs, focusing on the principle of justice and its application with participant selection is a really great way to improve diversity in biomedical research,” says Brandy M. Mapes, MLIS, translational research manager at Vanderbilt University Medical Center. “The study design can present barriers, and we should not exclude people because of too restrictive criteria or because [certain groups] are harder to reach.”
IRBs and research institutions should keep those principles in mind and prevent unintentional bias, restrictions placed on inclusion criteria, or strategies that could prove a barrier, she adds. (See story about expanding diversity in clinical trials in this issue.)
The glaring disparities uncovered during the pandemic have shown the world how poorly the American healthcare system fares in caring for minorities.
“With COVID-19, we find, again, poor outcomes,” Mitchell lamented. “We also recognize that participation in clinical trials gives us awareness of the disproportionate impact of participation, but also of outcomes.”
Demographic data on COVID-19 deaths, through July 20, showed that Black Americans died at a rate of 69 deaths per 100,000 people in the population. White Americans experienced a rate of 27 deaths per 100,000 people, and Latino Americans 33 deaths per 100,000 people. (For more information, visit: https://covidtracking.com/race.)
“Many people of color are essential workers,” she explained. “They are exposed to the public in greater numbers, and many had no access to personal protective equipment and other protective gear.” Also, minority communities include more multigenerational households, which contributes to infection risk for older adults.
Data on clinical trials ethnicity in the United States in 2019 showed that 80% of clinical trial participants were white, 6% were Black, and 10% were Asian, noted Annick de Bruin, MBA, director of research services at CISCRP in Boston. De Bruin spoke at the June 3 WCG web conference.
One challenge of enrolling more underrepresented minorities in clinical trials is the economic logistics of some trials, such as pediatric oncology research. At some children’s hospitals where patients are racially diverse, there might be one or two patients who meet the criteria for a particular study. But activating a clinical trial based on one or two patients is resource-intensive, says Nupur Mittal, MD, assistant professor of pediatrics at Rush University Medical Center in Chicago.
One solution is for research sites and IRBs to form collaborations that allow for resource sharing. (See story in this issue on how pediatric oncology research increased minority participation.)
Ingrained health disparities contribute to more illness among communities of color and the need for intensive care unit (ICU) care, noted Kevin Smith, MD, FACP, FAAP, chief medical officer at Loyola University Medical Center. Smith spoke at the June 26 web conference about COVID-19 and communities of color.
The pandemic is not necessarily a time when the healthcare and research community can fix health disparities, but they are seeing the consequences, Smith said. Healthcare providers saw evidence of the virus spreading widely through communities of color. When clinicians asked POC with COVID-19 if any family members were exposed to the virus, they often heard this answer: “Everybody else in my family had it,” he added.
Physicians and others on the frontlines of the pandemic witnessed a population-level view of COVID-19 and its outcomes by race and ethnicity, said Eli Rosenberg, PhD, associate professor in the department of epidemiology and biostatistics at the University of Albany (NY). Rosenberg also spoke at the June 26 web conference.
By focusing on outcomes in the Black community vs. the non-Hispanic, white community, researchers discovered the disparities are multilayered. “It could be many, many social and structural factors that simply expose minority groups disproportionately compared to other groups,” Rosenberg explained. “We see differences in the likelihood of needing hospitalization by race and ethnicity — again, with African Americans needing that intensive level of care.”
Recruitment methods are an issue when studies try to attract more underrepresented minorities. Researchers should develop a multilingual, targeted recruitment plan for minority communities, Mitchell said. The plan should emphasize the unequal risk and the importance of solutions that include clinical trial participation.
“We have to look at our discussions and presentations in those communities,” Mitchell said. “We should have a formal diversity strategy for recruitment, utilizing community organizations, including churches and individuals who are recognized and respected in the community.”
Research organizations also should work with institutions that have the infrastructure to conduct research in minority communities, she added.
Researchers should pay attention to enrollment and create diversity enrollment plans for studies. “This is not something that just happens,” Mitchell explained. “Engaging communities must be planned [early].”
For example, IRBs and research organizations could build relationships with minority institutions, including churches, and prepare multilingual recruitment plans and materials.
“Collaborate with organizations that have a history of engaging underrepresented minorities in our community,” Mitchell said. “It is so important that we recognize the factors that disproportionately affect people of color in the United States. We must utilize the information that we are learning and have learned from COVID-19.”
Data show online peer communities can help attract these groups. “Online peer communities are of high interest to underrepresented minorities,” de Bruin said. “Thirty percent are very interested in discussing and getting participation advice from peers online in a patient community. Forty-five percent said they were somewhat interested.”
IRBs could recruit more underrepresented minorities to their boards. Research organizations could encourage more minorities to become investigators. These efforts also could help with clinical trial recruitment of minorities.
“We recognize there are fewer minority investigators; therefore, one of our efforts is related to increasing the number of physicians and other clinicians from minority communities,” Mitchell said. “While African Americans account for 13% of the population of the U.S., African American physicians only account for 4%.”
To address the problem of too few minorities in clinical trials, research offices should look at all components contributing to this disparity.
“We should make sure there is equity in clinical trials,” Mitchell said. “We have one of the major efforts related to increasing the number of minority investigators and investigators who understand minority populations.”
Several months of data from the COVID-19 pandemic showed that African Americans and other people of color were disproportionately dying from the disease. Disparities in how COVID-19 affects minority communities highlight long-standing difficulties in achieving health equity in U.S. society, including clinical trials.
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