October 27, 2020 | As the pandemic continues, infecting over 30 million people and killing more than 1 million worldwide, emerging data suggest that COVID-19 is disproportionately impacting communities of color.

In the United States, Black people are dying at over two times the rate of White people nationwide, according to the COVID Racial Data Tracker. Latinx and Native American communities have also suffered from higher rates of mortality than their White counterparts.

As scientists race ahead to develop a safe and effective vaccine, some experts have highlighted the need to address the lack of diversity in clinical trials considering the populations at greatest risk stand to benefit the most from this research.

Detailing Disparities

A study published Aug. 17 by researchers at the University of Minnesota (DOI: 10.1001/jamainternmed.2020.3857) identified significant disparities in the prevalence of COVID-19 across racial and ethnic subgroups of the U.S. population among the 12 states that consistently reported this type of data during the study period. 

Their analysis of COVID-19 hospitalizations during a roughly two-month stretch found that the share of the hospitalizations of White patients was notably smaller than their share of the population in all 12 states whereas the percentage of hospitalizations among Black patients exceeded their proportion of the state population in all 12 states. The researchers also observed high hospitalization rates for Hispanic individuals in most states analyzed and for American Indian and Alaskan Native people in some states. 

These results are consistent with previous findings, the authors pointed out, such as an earlier Centers for Disease Control and Prevention (CDC) analysis (DOI: 10.15585/mmwr.mm6915e3) of over 500 hospitalizations that revealed disproportionately high COVID-19 hospitalizations for the Black population. Similarly, a study (DOI: 10.1377/hlthaff.2020.00598) of over 1,000 COVID-19 cases at a California health system observed that Black patients with COVID-19 are far more likely to be admitted to the hospital than their White counterparts. 

There have been various explanations that attempt to get at the underlying causes of these disparities found in COVID-19 infection, hospitalization, and death rates.

One group, for example, pointed out that the contribution of racial segregation has been largely overlooked. In a commentary paper published Aug. 19 (DOI: 10.1089/apc.2020.0155), researchers at amfAR, The Foundation for AIDS Research, noted that one way to make sense of these disparities is to do so within the context of HIV, which is also associated with racial and ethnic differences. 

By examining U.S. Census data, the researchers found that HIV diagnoses decrease as the proportion of white residents increases across U.S. counties, and COVID-19 diagnoses follow a similar pattern. COVID-19 diagnoses are far lower in U.S. counties with a high proportion of White people than more racially diverse counties.

Several factors contribute to the more significant COVID-19 burden in communities of color, the researchers noted, but they all stem from systemic racism. While many point to underlying health conditions as the source of COVID-19 racial disparities, they found that factors such as living in overcrowded households, living in areas with greater air pollution, and working at jobs that increase exposure to SARS-COV-2 were better predictors than any underlying health condition.

Another study published Sept. 8 (DOI: 10.1007/s40615-020-00853-0) identified a biological factor that may, at least in part, account for the higher prevalence of COVID-19 in Black populations. The research, conducted by biotech company BERG and scientists from the University of Oxford and Virginia Commonwealth University, highlights the increased frequency of a genetic aberration associated with increased susceptibility to lung and kidney dysfunction—both of which are risk factors for COVID-19 infection and fatality.

Importance of Enrolling Minorities in Clinical Trials

Some say there is a need to address the lack of diversity in COVID-19 clinical trials considering minority groups—particularly populations at greatest risk such as Black, Latinx, and Native American communities—have so much to gain from this research. 

“It is critically important that clinical trials of potential COVID-19 vaccines include representative samples of people that reflect the population at greatest risk for COVID morbidity and mortality,” said Don L. Goldenberg, emeritus professor of medicine at Tufts University School of Medicine. This includes minority groups as well as older individuals and anyone with a chronic medical disease. “Groups at highest risk are the ones most likely to benefit from an effective vaccine, and they should be the first to receive such a vaccine,” he told Clinical Research News.

“Black Americans tend to have the top underlying pre-existing medical conditions and worst outcomes for the conditions that also that puts them at higher risk for complications related to COVID-19,” including issues like high blood pressure, heart disease, diabetes, and lung disease, Magdalena Cadet, a rheumatologist and associate attending at NYU Langone Medical Center, told Clinical Research News.

It is important to enroll participants from minority groups because these individuals could be at risk for severe complications of COVID-19 infections, she adds, and their inclusion will help determine if a vaccine can prevent or reduce the severity of long-term complications.

A perspective paper published Aug. 11 (DOI: 10.1056/NEJMp2021971) pointed out that the lack of diversity in COVID-19 clinical trials could be the result of long-standing medical distrust. It may also be compounded by cost, including the hidden expense of fuel, parking, meals, and lodging. Other factors that may play a role, according to the researchers, include language barriers, reduced accessibility, poor health literacy, and biases against minorities. Yet another potential explanation is the lack of diversity among principal investigators.

Clinical trials will need to prioritize the inclusion of patient populations that reflect the pandemic demographics, they argue, to provide the data required for generalizing efficacy and safety outcomes across racial groups. Appropriate random sampling and expansion of clinical trial sites to vulnerable communities are potential solutions for improving the makeup of samples.

The standardized reporting of race and ethnicity categories could also enable “improved assessment of the generalizability of evidence-based interventions,” they added. Beyond that, researchers will need to face the challenge of developing strategies for recruiting participants from minority groups by “proactively addressing the possibility or fear of exploitation.”

“The public as a whole has an inherent distrust in the pharmaceutical industry,” added Mike Wenger, vice president of patient engagement at TrialScope, which works with clinical trial sponsors to maximize trial transparency, improve patient engagement, and accelerate study recruitment. “Since the coronavirus pandemic, the industry’s reputation has improved somewhat,” he told Clinical Research News. “Among minorities, however, and particularly Blacks, distrust remains a major barrier to clinical trial participation.” 

Historical factors contribute to this distrust and fear, he explains, such as the infamous Tuskegee study of the 1930s, in which members of the United States Public Health Service followed Black men infected with syphilis for decades without treating them. Another notable example is the case of Henrietta Lacks, a Black woman who died of cervical cancer. In the 1950s, unbeknownst to her or her family, doctors took her malignant cells, which reproduced indefinitely in culture. 

There is a whole array of additional factors that may also be playing a role. Socioeconomic status, for instance, presents a barrier to clinical trial participation. “Lower-income patients, many of whom belong to minority groups, may not be able to afford taking time off from work to participate in a clinical trial,” Wenger said. 

Transportation can pose a problem for people relying on public transit, and for Latinx patients, language can be problematic. “Understanding clinical trial information is complicated enough for those whose native language is English,” he noted. “For non-English speakers, it represents an insurmountable barrier.” Finally, geographical location can pose a challenge. Native Americans living in remote areas, for example, may not be near clinical trial sites.

Addressing the Challenge of Enrolling Minority Participants

Some steps can be taken to move in the direction of clinical trial diversity. “The best strategy is for the pharmaceutical industry to work with partners that have reach within different communities,” said Wenger. Certain patient and disease advocacy groups or online communities can be homogenous, so sponsors need to move beyond their current partnerships. 

Sponsors also need to increase access to clinical trials. They are doing patients a disservice by sending them to ClinicalTrials.gov for information, he says, because the site is not patient-friendly. Instead, they should use health literacy best practices, such as writing at a 6th-grade level, and should provide their own information on trials along with contact information. Also, clinical trial websites should have information made readily available in various languages to attract the broadest possible audience.

“There should be implicit bias training for all those who are involved with the vaccine trial, especially with recruitment and clinical trial design,” said Cadet. There should also be cultural competency training to identify any barriers that might subconsciously exist when recruiting participants and trying to obtain informed consent.

She indicated that increasing the recruitment of Black physicians as investigators, support staff, and nurses could help the Black community build more trust and communication, leading to improved dialogue between physicians and patients when discussing a vaccine trial’s details. Efforts to inform and engage minority communities are essential, added Goldenberg, “especially using influential members of each minority community to explain the importance of inclusivity in vaccine trials.”

According to Melva Thompson-Robinson, executive director of the Center for Health Disparities Research at the University of Nevada, Las Vegas, researchers cannot look at this scenario as what some have referred to as safari research. This, she explained, is where people go in, take a picture or a snapshot, collect their data, and then leave, similar to the way people do while on safari in the Serengeti.

It is essential to understand, rather, that these are real people with real challenges and issues, and it’s crucial that the research isn’t being conducted just for the sake of getting published, going after grants, or seeking promotion and tenure. 

There’s a sense of wanting to do right by one’s community for researchers of color, she told Clinical Research News, because “these aren’t just people who look like me,” she explained. “These are people that I may go to church with, or that my kids may play sports with, as opposed to just people that I’m collecting data from.”

Rather than returning to communities and delivering a formal presentation, there is an opportunity to talk about what research findings mean for that community and discuss any next steps. There is also a need to involve the community in what researchers are doing, she said, “so that we’re not making them feel like victims but really as equal partners in the research.” 

“For researchers of color, we’re often viewed as the gatekeepers to the community when it comes to research,” Thompson-Robinson said, “and so we have to feel comfortable about the research that our colleagues are proposing.” That way, if things go awry, “either we can help make them better or we can act in the best interest of the community.”

“Because at the end of the day, we’re still part of the community,” she added. “We’re not researchers 24/7, but we are part of the community 24/7.” So rather than assuming people are just going to jump in and take part in research, it’s worth asking: “How do we do this in a way that’s respectful and meaningful to everyone involved?”

Paul Nicolaus is a freelance writer specializing in science, nature, and health. Learn more at www.nicolauswriting.com.