New study demonstrates community engagement efforts are critical to ensuring the equitable inclusion of BIPOC communities in vaccine clinical trials
SEATTLE — October 19, 2021 — A team of research experts from the COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Research Center, has 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 BIPOC communities in infectious disease research as a critical component in efforts to increase vaccine confidence, acceptability and uptake of future approved products.
“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 by building reputations of trustworthiness as researchers and institutions.”
The study analyzed 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 are 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 (CTRIS) at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) 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.”
Four methods for engaging with BIPOC communities included:
“These results show that equitable inclusion of BIPOC communities is possible. We have known that it is necessary given the long standing social, structural and economic inequities that BIPOC communities face,” Andrasik said. “We have to invest in connecting with the community and ensuring meaningful community involvement in every step of the research.”
The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. Through the CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the pressing need for vaccines and antibodies against SARS-CoV-2. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. The CoVPN is headquartered at the Fred Hutchinson Cancer Research Center.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network and COVID-19 Prevention Network.
Content last reviewed on November 10, 2021