A matter of trust: Reengaging communities of color in clinical trials

For Argentino Calvo, a retired firefighter and paramedic from Bluffton, South Carolina, joining a COVID-19 vaccine trial was not just a personal choice but an investment in the health of his community.

Calvo participated in the Novavax vaccine trial at MUSC, which was part of a large-scale study that recruited over 30,000 patients across 119 study sites in the United States and Mexico.

Calvo, whose wife is an oncology nurse, has since become a COVID-19 ambassador to his local Latino community, breaking language barriers to ease anxiety surrounding clinical trials and vaccine development.

“Being Hispanic, most of the Latino community knows me in my town,” said Calvo. “Sometimes non-English speaking people only get half of the message, so I am trying to pass on the knowledge that I have.”

Clinical trials determine the fate of most any medical intervention, be it a drug, device or vaccine. Unfortunately, clinical trial participants don’t always accurately represent the wider population.

A 2021 study in the Journal of the American Medical Association analyzed 230 U.S.-based vaccine clinical trials from 2011 to 2020 and found that out of nearly 220,000 study participants, more than 75% were white. Compared with census data, people of color were underrepresented, and fewer than half of the trials even reported ethnicity.

“When you think of clinical trials, there’s that fear of being a lab rat. But now, having gone through it, I would gladly do it again to make life better for others.”

-- Vaccine trial participant Warren Marcus

Barriers to recruiting people of color into clinical trials include disparities in access to health care and a distrust of medical research due to past abuses. These include the failure to provide penicillin to the Black male participants in the infamous Tuskegee Syphilis Study, even after it was found to cure syphilis, and the  nonconsensual use of tissue from Henrietta Lacks.

Marvella E. Ford, Ph.D., a professor in the Department of Public Health Sciences and the associate director of cancer disparities and population sciences at Hollings Cancer Center, understands this distrust well. Ford participated in Tuskegee University’s first ethics conference in 1996 that met to discuss the ramifications of the Tuskegee study.

A number of survivors of the study were also present. Instead of expressing distrust in clinical research, however, Ford recalled that they voiced concerns through their attorney, famed civil rights lawyer Fred Gray, that poor clinical trial diversity would mean their community would not benefit from the latest medical advances. Gray explained that his clients feared that their suffering would have been in vain.

“Mr. Gray said the men were proud of the fact that, because of what they went through, we now have safeguards in place to protect future generations of trial participants,” said Ford.

These safeguards include institutional review boards to scrutinize the ethical and scientific merit of clinical trial protocols, data and safety monitoring boards to oversee the safety and effectiveness of the treatments being tested and an informed consent process that gives participants ongoing information so they can decide whether to enroll or stay in a clinical trial.

 

Charnele Handy, clinical trials program coordinator for the South Carolina Clinical & Translational Research (SCTR) Institute at MUSC, uses her scientific background and perspective as an African American woman to build trust with participants of color.

“As an African American and a female, I can give you a little more comfort in feeling that I understand and empathize with the trauma we’ve experienced,” said Handy. “Let me show you that I’m part of a team that’s working to move forward.”

 

Warren Marcus, a Gullah Geechee sweetgrass artist and caretaker, was in the AstraZeneca vaccine trial at MUSC, which recruited more than 650 people in Charleston. While he was initially hesitant to participate, Marcus had a pleasant experience in the trial.

“When you think of clinical trials, there’s that fear of being a lab rat,” said Marcus. “But now, having gone through it, I would gladly do it again to make life better for others.”

Participation from communities of color in clinical trials helps to ensure that the treatment is safe and effective for everyone, as different populations may respond differently to medical interventions.

To improve clinical diversity, Handy said that it is vital to acknowledge the injustices of the past and facilitate open communication between diverse groups of scientists, health care providers and local community members.

“Don’t dismiss the trauma,” she added.

Ford, who also serves as the co-director of the Black Faculty Group, has worked hard to get the word out to the Black and Latino communities that it’s vitally important to participate in trials as well as to receive the COVID-19 vaccine – especially with such a high prevalence of severe cases in minority populations and the recent uptick in numbers. At the same time, she stresses the importance of building trust and confidence in health care in these communities. “We want to be a resource for community members,” she said. “We want to meet with them and talk about their concerns.”

Retired Bluffton firefighter Calvo appreciates Ford’s approach. “It's not just one person's problem; it’s everybody's,” he said. “I would encourage everyone to participate in clinical trials.”

Warren agreed wholeheartedly. “You’re not just doing it for you, you’re doing it for generations to come.” he added.

To learn more about participating in clinical trials at MUSC, visit Clinical Trials and Research at MUSC.