A team of research experts from the COVID-19 Prevention Network, or CoVPN, headquartered at Fred Hutchinson Cancer Research Center, have demonstrated that through robust community engagement, equitable inclusion in vaccine clinical trials can make a powerful impact in the health of underrepresented communities.
Recent data highlights the absence of Black, Indigenous and people of color (BIPOC) communities in vaccine clinical trials. The new study, published in the journal PLOS ONE, discusses the need for engagement of these communities in infectious disease research as a critical component in efforts to increase vaccine confidence, acceptability and uptake of future approved products.
An excerpt from a February 2021 Fred Hutch News Service story:
... For more than a decade, psychologist Dr. Michele Andrasik has been working in Seattle on ways to increase opportunities for underrepresented minorities at risk for HIV to participate in clinical trials of vaccines and drugs to prevent it.
Last spring, as COVID-19 began to tear through American cities and was disproportionately affecting communities of color, her focus at Fred Hutch pivoted to the vital work of engaging these same communities in trials of coronavirus vaccines.
“Unfortunately when anything like this hits in the U.S. or in the world, it’s going to be the individuals who have devalued identities, who are marginalized and disenfranchised, who will bear the greatest burden,” said Andrasik, a senior staff scientist who is director of social and behavioral sciences and community engagement at the Hutch-based HIV Vaccine Trials Network, or HVTN. ...
— Read more about how years of working to involve marginalized or stigmatized populations in HIV trials informs efforts to reach those who are most at risk for COVID-19.
“There has been discourse stating that it is challenging and there are too many barriers to engaging with BIPOC communities,” said Dr. Michele Andrasik, a senior staff scientist at Fred Hutch and lead author of the study. “We are hoping that this shows these are surmountable barriers, and it is possible to overcome them through long-term investments in relationships within the community and building reputations of trustworthiness as researchers and institutions.”
The study analyzed the demographic and enrollment data across the Phase 3 COVID-19 vaccine efficacy trials to inform future efforts to ensure inclusive participation. Across the four U.S. government-funded COVID-19 vaccine clinical trials for which data is available, 47% of participants enrolled at CoVPN sites in the U.S. were BIPOC. White enrollment outpaced enrollment of BIPOC participants throughout the accrual period, requiring the implementation of strategies to increase diverse and inclusive enrollment. Trials opening later benefitted considerably from strengthened community engagement efforts, and greater and more diverse volunteer registry records.
“Misinformation and distrust of science are important barriers to research participation,” said Dr. George Mensah, director, Center for Translation Research and Implementation Science at the National Heart, Lung, and Blood Institute (part of the National Institutes of Health), and one of the authors of the study. “This study showed us that if you take the time to engage communities and use promising practices to address misinformation and distrust, you can be successful in increasing BIPOC community participation in clinical research.”
Read more, including about the CoVPN's methods for engaging with BIPOC communities, in the complete CoVPN/Fred Hutch press release on this study.