Participation in clinical trials among Black people is low, according to Food and Drug Administration statistics. Still, including them in coronavirus vaccine trials has been a stated priority for the pharmaceutical companies involved, since African American communities, along with those of Latinos, have suffered disproportionately from the pandemic.
The ongoing trials are moving at a pace that is unprecedented for medical research, with the Trump administration’s vaccine acceleration effort dubbed “Operation Warp Speed.” Yet recruiting minority participants requires sensitivity to a mistrust borne of past and current medical mistreatment. Trust-building cannot be rushed.
So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials — and targeted outreach efforts to recruit more minorities have been slow to launch.
Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. At Meharry Medical College in Nashville, Tennessee, researchers have set up in-person meetings with patients they already know. Earlier this month, a half-dozen patients gathered in a cramped conference room on campus. They snacked on turkey sandwiches and potato chips and listened to the pitch from their physician, Dr. Vladimir Berthaud.
“What’s the best hope to get rid of this virus?” he asked them.
“Vaccination,” they replied.
Then Berthaud followed up: “So raise your hand if you would like to take the vaccine?”
Some hands shot up, but not all.
“I ain’t going to be the first one, now,” said Lanette Hayes.
Katrina Thompson said she does eventually want to get a shot for protection against the coronavirus. She explained she’s especially worried about all the residents of her apartment building who don’t seem to be doing the basics of covering their coughs.
“The word ‘vaccination’ don’t scare me,” she said. “The word ‘trial’ do.”
Black Americans have reason to be suspicious — stemming beyond the well-known Tuskegee experiments, in which Black men with syphilis were deceived and mistreated as part of an experiment that went on for decades. Many Black Americans report ongoing mistreatment by medical providers today.
Berthaud is recruiting patients for a clinical trial site he will oversee in Nashville, and he would like more than 300 people of color to enroll. Berthaud, who is Black and from Haiti, appeals to his patients’ sense of duty.
“If you don’t have enough people like you in those vaccine trials, you will not know if it works for you,” he told them. “You will not know.”
For most of the current coronavirus vaccine trials, recruitment mainly takes place online — which often results in mostly white people enrolling.
That’s why Meharry researchers are wooing Black patients with a personal invitation. But they’re not recruiting for the phase 3 trials underway. Meharry’s first trial, for a vaccine candidate by Novavax, doesn’t launch until October.
The company did not respond to requests for comment but publicizes demographic statistics about the clinical volunteers every week. While somewhat more inclusive than the typical clinical trial, it still is not a good representation of the diversity of the U.S.
For the coronavirus vaccine in particular, the National Institutes of Health has suggested minorities should be overrepresented in testing — perhaps at rates that are double their percentage of the U.S. population.
“We say we want to have everybody included, but really the effort for the vaccinations — in a sense — [is] starting the same way they’ve always been,” said Dr. Dominic Mack, of Morehouse School of Medicine in Atlanta.
Dr. Vladimir Berthaud and Dr. Rajbir Singh recruit patients for a COVID-19 vaccine trial at Meharry Medical College in Nashville, Tennessee.
He’s working with the NIH to make sure people of color are included in COVID-19 research. Mack said there are no shortcuts if medical research is going to reflect the diversity of the U.S. It takes time to build trust and meaningful relationships with people who have endured a history of abuse or neglect by medical providers, and exclusion from biomedical research and decision-making.
“Now, that being said, the only thing we can do is what we’re doing,” he said — by which he means respectful, unrushed outreach and dialogue.
The primary effort, called the COVID-19 Prevention Network, taps into four existing clinical trial networks designed to advance HIV research. Those networks are based in Seattle, Atlanta, Los Angeles and Durham, North Carolina.
One project will be led by the Rev. Edwin Sanders II of the Metropolitan Interdenominational Church in Nashville. It will involve seven “faith ambassadors” and 30 “clergy consultants” in the African American community working to dispel myths and increase trust in the clinical trial process. But Sanders cautioned this is not about a hard sell. It’s not his job to preach trial participation from the pulpit, he said.
“We are not out beating the drum,” he said, acknowledging that congregants may have legitimate concerns. “I am not going to do anything more than make sure people are able to make an informed choice.”
The danger in lunging for big diversity goals is that it could spark a backlash, meaning minorities might be even less willing to participate, said associate professor Rachel Hardeman, who studies health equity at the University of Minnesota. It’s important that the doctors doing the asking look like the people they’re appealing to, she said.
“It’s racial concordance,” she explained. “It offers this feeling of, ‘You know who I am, you know where I come from, you have my best interests at heart.’”
Historically Black medical institutions in the U.S. are uniquely positioned to do this work. While they haven’t been on the leading edge of recruitment for vaccine trials, they intend to play an important part. The president of Nashville’s Meharry Medical College, Dr. James Hildreth, is an infectious disease researcher. But instead of overseeing the trial site being hosted on his campus, Hildreth has a more modest goal in mind: He plans to participate as a patient, and urge others to join him.
“I think my role is more important in advocating for people to be involved in vaccine studies than to be one of the leaders of the study,” he said.
So at Meharry, Berthaud is the principal investigator. As lunch wraps up in the crowded conference room, he has managed to win over some holdouts.
“Where is the line?” asked Robert Smith. “Where do we sign?”
Smith, with his young grandson in tow, didn’t raise his hand at first when asked if he’d take the vaccine. But after listening to Berthaud, Smith agreed to participate in the clinical trial — for no other reason than the trust he has in Berthaud, his longtime physician.
“He’s not only my doctor; he’s proven that he cares about me,” Smith said.
Persuading hundreds or thousands of Black Americans to sign up will be difficult. But researchers hope their outreach efforts will at least result in more minorities agreeing to take an approved vaccine when available.