Will COVID Vaccine Trials Reflect U.S. Diversity?
Those trial networks were chosen in large part because they have rich relationships in Black, Latino and other minority communities, said Stephaun Wallace, director of external relations for CoVPN. The hope is to leverage existing connections based on trust and collaboration.
“Our clinical trial sites are prepped and ready to engage diverse people,” Wallace said.
Wallace acknowledged, however, that attracting a diverse population requires investigators to be flexible and innovative. There can be practical problems. Clinic hours may be limited or transportation may be an issue. Older people may have problems with sight or hearing and require extra help to follow protocols.
Distrust of the medical establishment also can be a barrier. African Americans, for instance, have a well-founded wariness of medical experiments after the infamous Tuskegee Study and the exploitation of Henrietta Lacks. That extends to suspicion about recommended vaccines, said Wallace.
“Part of the consideration for many groups is not wanting to feel like a guinea pig or feel like they’re being experimented on,” he said.
Moderna, which plans to launch its phase 3 trial Monday, said the company is working to ensure participants “are representative of the communities at highest risk for COVID-19 and of our diverse society.”
However, results of the company’s phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were Black, one was Asian and one was Native American. Forty were white.
Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials assess the efficacy of the drug in tens of thousands of people.
Investigators at nearly 90 sites across the U.S. are preparing now to recruit participants for Moderna’s phase 3 trial. Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine, will seek 750 volunteers at three Atlanta-area sites. Half will receive the vaccine; half, placebo injections.
Del Rio has had marked success recruiting minorities for HIV trials and expects similar results with the vaccine trial. “We’re trying to do our best to get out to the communities that are most at risk,” he said.