Photo by Octavio Jones / Getty Images
For more than a decade, psychologist Dr. Michele Andrasik has been working in Seattle on ways to increase opportunities for underrepresented minorities to participate in HIV clinical trials of vaccines. and drugs to prevent it.
Last spring, when COVID-19 began tearing through American cities and making a disastrous impact on color communities, its focus at the Fred Hutchinson Cancer Research Center was tied to the important work to one of these communities to be involved in coronavirus vaccine trials.
“Unfortunately, when anything like this hits the US or the world, it is the people who have diminished identities, who are marginalized and dispersed, who have the biggest burden, ”said Andrasik, senior scientist who is the director of social sciences and behavioral and community involvement at the Hutch – based HIV Vaccine Testing Network, or HVTN.
Statistics compiled by the Centers for Disease Control and Prevention show that among the 350,000 who died from COVID-19 in the U.S. last year, white people accounted for only 63% of deaths . But the latest census data shows that white people make up 76% of the U.S. population. Black people accounted for 15% of deaths, representing less than 14% of the population.
“It is no surprise to any of us that differences in COVID-19 results reflect the differences we see in other diseases,” Andrasik said. These differences have long been reflected in the preclinical representation of minority groups in clinical trials of new vaccines and drugs.
Last June, Dr. Tony Fauci acquired vaccine testing experience at HVTN to help coordinate large-scale clinical trials of COVID-19 vaccines. Employees shifted their specifications to work for the newly created Covid-19 Prevention Network, or CoVPN – its operating center led by HVTN co-founder and Hutch virologist, Dr. Larry Corey.
Fauci looked to HVTN not only because of its network of vaccine test designers and vaccine monitoring sites, but also for its behavioral health experts like Andrasik, people with a deep understanding of the limiting barriers engagement with members of marginalized communities.
Andrasik applies behavioral health science to address the issues and fears of communities that have historical reasons to rely on medical research. The only communities that do not have access to quality health care and feel that their health concerns are routinely eradicated by doctors are, for some of the same reasons, more accessible. injured to infectious diseases such as HIV and COVID-19.
Work to address these structural inequalities begins at the beginning of the clinical trial process, when the protocols outlining the objectives of the study are extracted and its procedures designed. .
“We need to have like-minded people of color and trust in their communities to review these protocols and revise consent forms,” Andrasik said.
From there, the reach-out effort is trying to prove that their researchers deserve the trust of the communities. Here, the years work to marginal numbers or stigma in HIV testing inform efforts to reach those most at risk for COVID-19.
“Most of what I have learned is about engaging with communities through experience and building relationships,” she said. “Relationships marked by trust are at the heart of what we do. ”
New study reveals poor history
U.S. efforts to include participation among women and ethnic minorities in vaccine clinical trials are spanning decades, but the history is not good. In 1993, the National Institute for Health Rehabilitation’s ACHD required the inclusion of “appropriate” women and ethnic minorities in clinical trials. But a study published today in the online journal JAMA Network Open shows that these efforts have fallen short.
Researchers for that study, including Andrasik and Hutch’s infectious disease physician Dr. Steven Pergam, found that among 230 vaccine tests conducted from 2011-2018, only 58% reported the race of the participants and only 34% reported ethnicity.
Although women were on average underrepresented in that decade of trials (56% of participants v. 51% of the U.S. population), the study found – among the tests that provided data on race and ethnicity – detailed production was sufficient. For example, Blacks accounted for 13.9% of the U.S. population in 2018, but made up only 10.6% of trial participants during the study period; Hispanics accounted for 18.5% of the population but only 11.6% of participants, the researchers found.
“The fundamental question is that we need to do better work to target those numbers,” said the co-author of the study Pergam. “It almost opened my eyes. I expected a lot better than we saw. ”
The gap in reporting racial and ethnic data as ordered is particularly difficult, Pergam said. The authors of the study concluded that “diversity registration targets” should be included for all vaccine testing.
“Clinical trials need to be invested in supporting inclusion. It can’t be a billing service, ”Pergam said in an interview. “This has to be something where you have to provide support to encourage diversity, and if you have to slow down the test to make sure registration is appropriate, so be it.”
Photo by Robert Hood / Fred Hutch News Service
One reason researchers stress the importance of promoting diversity in vaccine trials is to worry that the racial inequalities in the combination of these studies may play out further. on the distribution of permitted vaccines.
Dr. Stephaun Wallace, HVTN’s director of external relations, said an effort to reach out in COVID-19 vaccine trials has involved participation from underrepresented minorities, and hopes that this will reduce immunization in these communities as vaccine supply increases.
A recent study by the Kaiser Family Foundation using state-reported COVID-19 data found “a relatively stable pattern of Black and Hispanic people receiving smaller portions of vaccines compared to the proportion of cases and deaths compared to the total population. ” He found that the vaccination rate for white people (10%) was more than three times higher than the rate for Hispanics (3%) and twice as high as the rate for Blacks (5%).
Wallace would like to see participation in trials and administration of vaccines according to the demographics of those most at risk for the disease.
“There is always room for improvement,” he said. “As we get closer to the proportion of people of color in the population, it would be closer to getting closer to the percentage of disease burden. ”