More than 350,000 people said they were interested in volunteering for a COVID-19 vaccine trial in the United States, and only 10% of those who signed up are Black and Hispanic. Actual trial enrollment among two companies with large COVID-19 vaccine trials in the U.S. includes only one in five volunteers who are Black and Hispanic.1

“The COVID pandemic had a disproportionately bad impact on minority communities. Some people are not interested in participating in clinical research, given historical research abuses,” says Alison Bateman-House, MPH, PhD, assistant professor in the division of medical ethics at NYU Grossman School of Medicine in New York City.

The authors of a new study examined two months of COVID-19 hospitalization data in 12 states. They found hospitalizations of white patients was much lower than their share of the population, while Black patients and Hispanic patients were overrepresented among those hospitalized.2

For example, in Virginia, 36.2% of hospitalizations were among Hispanic individuals, while they only account for 9.6% of the population. In Ohio, 31.8% of hospitalizations were among Black patients, while they account for 13% of the state population. These data suggest that even more Black and Hispanic people should be enrolled in clinical trials involving COVID-19 vaccines and therapeutics. Instead, their representation is lower.

There are multiple reasons why minorities are underrepresented, including historical research atrocities, says Karla Haack, PhD, lecturer of anatomy and physiology at Kennesaw State University in Kennesaw, GA. Haack also is chair of the diversity and inclusion committee for the American Physiological Society.

“We have a history in the United States of cruel studies like Tuskegee, using samples like Henrietta Lacks’ tissue, and unethical experiments on prison populations,” Haack says. “We have a historical precedence in the U.S. of mistreating Blacks when it relates to medical experimentation.”

Study recruitment problems also relate to systemic disparities in America, including the lack of Black and Hispanic professionals in clinical trials, as well as in medical care, she notes.

“If we had more healthcare workers who reflected the communities they serve, then that in itself would be trust-building,” Haack says. “If someone comes from a similar community or background as you, it gives you a sense of being in an in-group with your healthcare provider.”

The racial disparities in COVID-19 trial enrollment is particularly disheartening considering the pandemic has disproportionately harmed Black and Hispanic communities.

Data show that Black and Hispanic Americans are three times more likely to become infected with SARS-CoV-2 than white Americans. (More information is available at: https://bit.ly/3k9PsvI.) Data from the COVID Tracking Project show Black people are dying at 2.4 times the rate of white people, and account for 21% of COVID-19 deaths where the race is known. (Find out more at: https://covidtracking.com/race.)

COVID-19 exploits existing health access and treatment disparities among Black and Hispanic populations, says Wenora Johnson, a cancer research and patient advocate. Johnson spoke at an Aug. 19 WIRB-Copernicus Group webinar.

“Without affordable wages, one cannot afford healthcare,” Johnson says. “When you don’t have insurance, your health suffers more and you become more susceptible to viruses like COVID-19.”

Persistent inequity throughout society leads to a healthcare system that exacerbates distrust among minorities, Haack says.

“We know that the doctor-patient relationship, particularly in the United States, has distrust because of implicit or explicit biases that minority populations may experience,” Haack explains. “You have historical precedent and historic distrust and inequality to healthcare access. All of those things combined makes it unsurprising that there are fewer Black and Hispanic populations volunteering for vaccine trials than there are whites.”

Research organizations need to reach out to minority communities to increase representation in clinical trials across the board, perhaps even with TV commercials of actors representing clinical trial volunteers, Johnson says.

“I have yet to see one commercial with a person of color telling us about the clinical trial process. Let’s not do this in the future — it needs to be done now,” Johnson adds.

“Some of the conversations we’re having now are not unique to COVID, but the pandemic sets light on inclusion in clinical trials,” says Aisha Langford, MPH, PhD, assistant professor in the department of population health at NYU Grossman School of Medicine, and co-director of the Clinical and Translational Science Institute at NYU Langone Health. “Different racial and ethnic populations and others are disproportionately affected by COVID-19, including African Americans, Hispanics, older adults, and people in higher-risk occupations like grocery store workers, cleaners at hospitals, delivery drivers, people working in restaurants, and folks who have a lot of contact with the general public.”

Clinical trials need people from these groups to enroll in COVID-19 research. They should be openly recruited and asked to enroll, Langford says.

“A lot of times, racial and ethnic minorities are never really asked to participate in trials,” she says. “Many times, they are not aware of clinical trial opportunities, and they are not explicitly invited.”

When researchers say they tried to include minorities, Langford says her questions include: “What is your method for recruitment? Did you get the work out? Did you invite people?”

With COVID-19 vaccine trials, much of the work is conducted at academic medical centers and not necessarily in communities where racial minority populations are receiving their medical care. “Many groups are starting to think about community engagement, and we need to start to think about how to partner with community-based organizations, federally qualified health centers, and community hospitals where people are getting their care,” Langford says.

If someone lives a 45-minute drive or subway ride away from the center that is conducting a COVID-19 vaccine trial, then that distance would be a barrier, she adds.

IRBs can help reduce disparities if they ask researchers about their efforts to recruit and reach out to minority communities. “If I were on an IRB, I would want to see at least the intention or solicitation of X number of volunteers coming from different racial and ethnic backgrounds,” Haack says.

Research organizations could partner with ethnic communities and groups. They also could contact college student populations to form partnerships and champion hiring these students onto research teams, she adds.

“It doesn’t take much for people to see themselves reflected on the other side of the table,” Haack says.

Taking concrete steps, including outreach to minority communities and hiring minority students as interns, are good, concrete steps they could take to chip away at disparities, she says.

The COVID-19 pandemic gives IRBs and research communities a rare opportunity to work toward change and reducing healthcare and research disparities. “We are really at a tipping point, where I think it is impossible to not see or recognize these longstanding, historic inequities that have existed in our country,” Haack explains. “Given the fact that the pandemic is disproportionately impacting communities of color, we really have an opportunity to reach out and fix some of those historic inequities.”

REFERENCES

  1. Johnson CY. Large U.S. covid-19 vaccine trials are halfway enrolled, but lag on participant diversity. The Washington Post, Aug. 27, 2020. https://www.washingtonpost.com/health/2020/08/27/large-us-covid-19-vaccine-trials-are-halfway-enrolled-lag-participant-diversity/
  2. Karaca-Mandic P, Georgiou A, Sen S. Assessment of COVID-19 hospitalizations by race/ethnicity in 12 states. JAMA Intern Med 2020; doi:10.1001/jamainternmed.2020.3857. [Online ahead of print].