As reported August 16 by CNN, our efforts to find a COVID-19 vaccine may be delayed as not enough minorities have been recruited to join trials. Out of 350,000 people who have registered for a trial, 10% are Latino or Black, according to Dr. Jim Kublin of the Covid-19 Prevention Network. Since trials should reflect the whole population that is affected, “that’s not nearly enough.” Notably, over half of COVID-19 cases in the US, “have been among Black and Latino people.” NIH Director Francis Collins gave Moderna’s Phase 3 trial a “C” grade for recruiting ethnic minorities. Without adequate minority participation, it is possible that vaccine approval may be delayed. Myriad factors are at play here: historical abuse of Blacks such as the infamous Tuskegee experiments, current health care disparities, social unrest, and the burdens of a somewhat faltering economy. Renee Mahaffey Harris, of the Center of Closing the Health Gap in Cincinnati, says “When we Black people hear ‘clinical trials,’ we think ‘we’re not going to be researched on,’ and that’s across economic status and across educational status, not just one sector.”
Because they may be affected differently from Whites to a vaccine, federal law and NIH policy require minority inclusion in clinical trials. If patient demographics are not representative, the Data Safety Monitoring Board could slow a trial down to ensure minority participation. Another key issue is that, “researchers seek out study subjects who are most likely to come in contact with the virus in their daily lives.” Health care workers and minorities are both more likely to encounter SARS-CoV-2, and the latter group is susceptible due to essential in-person jobs and multigenerational families. CDC data shows that Blacks, who make up 13% of the US, have 22% of the COVID-19 cases, while Latinos, who make up 18% of the US, account for 33% of cases. Dr. Fauci has made clear that community players, such as Mahaffey Harris, are the best ones to “sell” trial participation in the Black community.
Historical Wrongs Lead to Suspicion
August 5, Harris got a call from a doctor asking for her help in recruiting minorities for a Moderna vaccine trial, and she demurred. She won’t recruit folks because she does not trust the system: “I am always cautious when I’m being contacted by anyone involved in pharmaceutical research because I, as a Black woman, never want to be a part of engaging and recruiting people for research that ends up having any bias in it or any hint of impropriety, like what happened at Tuskegee,” she said. She did tell the doctor that she would meet with him this month. NIH has engagement efforts with many organizations, such as representatives of Black churches and medical professional groups. Some of Moderna’s sites are commercial and some are a part of the NIH network; the later are the latest to open. NIH set up the Covid-19 Prevention Network in order to recruit for trials. Through August 26 they will be releasing print, radio, and social media communications targeted to minorities, among others.
While “Warp Speed” is fast, Black leaders told CNN that gaining trust in the community, “doesn’t happen at warp speed.” In the Tuskegee experiment, from 1932 to 1972 Black men were unknowingly subjects in a syphilis study and were not offered known, effective treatment. From the 1940s to the 1970s mostly Black subjects were exposed to potentially lethal quantifies of radiation, says Harriet Washington, the author of “Medical Apartheid: The Dark History of Experimentation from Colonial Times to the Present.” Per Washington, Blacks have less access to physicians, they are believed less by doctors, and medical technology is withheld. “Now we’re approaching them with an experimental vaccine that we’re offering as a benefit — but asking people to trust that is asking a great deal,” she said. “There’s a risk to taking an experimental vaccine. There’s just no way to sugar coat that.” Black leaders say they were contacted days or weeks before subjects were needed, not giving them time to respond. They argue that long-term investment in relationships is needed, as opposed to a last-minute plea.
TrialSite’s 2018 Research Survey; Yale Shows How to Diversify Research
Back in 2018, TrialSite commissioned an African American Clinical Research Disparity Survey, as we covered here. At the time, we reported that the survey was motivated by the well-known disparities in outcomes impacting Black Americans. These include higher death rates from many major diseases. The survey focused on Texas, and the team surveyed 100 Black Americans. We found respondents willing to answer the survey, and once they were comfortable, they were willing to provide their thoughts on how health systems and even Pharma can engage with the community for better trial participations. Like CNN, we found core themes of mistrust driven by historical precedent, socioeconomic barriers, and perceptions of unequal treatment.
In an August 18 article, we argued that “Yale Shows a Path Forward for Research.” We noted that the Ivy League school has deep ties to New Haven’s largely Black and Latino community. Yale has sought to bring together its research, academic, and community clinic roles for an integrated approach. About ten years ago, Yale instituted a Cultural Ambassador program to help broaden community participation in research. Yale reported, “great success in engaging populations of color in clinical research” after partnering with the Junta for Progressive Action and the African Methodist Episcopal Church. The Reverend Elvin Clayton said, “When we started talking about clinical trials in our community, people of color represented only 3%-6% of the participants in clinical trials.” He says that figure is now, “between 30%-50% participation, and in some trials, over 90%.”
Clearly places such as Yale and New Haven’s communities of color have found a common ground. That’s possible elsewhere.