Increasing BIPOC inclusion in clinical trials

From the COVID-19 Prevention Network, Vaccine and Infectious Disease Division

Black, Indigenous, and People of Color (BIPOC) communities experience health inequities due to pervasive social and economic inequities. However, despite a disproportionately high burden of both non-communicable and infectious disease, BIPOC people are less likely to be included and participate in clinical trials. This discrepancy breeds healthcare research that does not include populations that stand to benefit most, facilitating further disease burden in BIPOC communities. BIPOC participation and inclusion in clinical trials must be increased to assist in breaking this cycle. The COVID-19 Prevention Network (CoVPN) implemented methods which have previously been successful in HIV vaccine studies to successfully promote BIPOC recruitment in four recent COVID-19 vaccine trials, and published the outcomes in PLoS ONE.

This work, led by Michele Andrasik, Gail Broder, Stephaun Wallace, Richa Chaturvedi, along with Sally Bock and collaborators from Fred Hutch and other institutions, defines the successful community engagement strategies that were recently executed by the CoVPN to increase BIPOC engagement in clinical trials. The four parts of this community engagement program were as follows:

1)    Utilization of Community-Based Participatory Research approaches to meaningfully involve communities throughout the research process.

This arm is focused on educating communities to eliminate misconceptions, misinformation, and myths that may prevent BIPOC participation through the inclusion of community members at all stages of research. Community Working Groups (CWG) and Community Advisory Boards (CAB) were utilized during protocol development and provided guidance. Additionally, panels of experts from priority populations such as Native/Indigenous, Black/African American, Hispanic/Latino/a, and Older Adult/Veterans were created, each comprised of both scientists and community leaders. This collaboration ensured that that outreach efforts contained culturally appropriate and inclusive language, comprehensible materials, and materials were presented in a manner that was accessible to the target populations.

US diverse enrollment across the NIH-funded Moderna, AstraZeneca, J&J, and Novavax trials.
US diverse enrollment across the NIH-funded Moderna, AstraZeneca, J&J, and Novavax trials. Figure from publication.


1)    Stakeholder engagement and building trust

This arm of the community engagement strategy prioritized collaborating with institutions and organizations with whom trusting relationships have already been established by BIPOC communities, and establishing new relationships with institutions and organizations to reach broader audiences. This partnership facilitated building trust among BIPOC communities, distribution of accurate information through trusted community voices, and promoted understanding of community contexts, needs, and fears.

2)    A faith initiative

The HVTN has a successful historical relationship with faith communities, a rapport which the CoVPN leveraged to improve engagement in COVID-19 clinical trials. Faith leaders from various faith traditions were appointed as CoVPN Faith Ambassadors to support education and communication of scientific information through their respective faith communities and networks.

3)    Communications and community influencers

In September 2020, the CoVPN launched an extensive marketing and communications campaign to educate BIPOC communities on COVID-19 vaccine trials based on community concerns gleaned through interviews and surveys. The campaign used a combination of television, radio, internet audio, social media, trusted organizations, and celebrity personalities to increase clinical trial transparency and explain scientific concepts in language appropriate for the public.

Looking at the first four COVID-19 clinical trials that have completed accrual where these CoVPN community engagement strategies were implemented, Dr. Andrasik and colleagues analyzed the racial and ethnic demographic data of the enrolled participants across the US-based, CoVPN-affiliated clinical research sites, and found that 47% of all participants enrolled were BIPOC persons. At many sites, White enrollment outpaced a slower-but-steady BIPOC enrollment, and intentional recruitment of BIPOC persons was necessary. In these cases, CoVPN sites were more successful in recruiting BIPOC participants than non-CoVPN sites, suggesting that the 4 community engagement strategies were beneficial.

Together, these outcomes demonstrate that the committed community engagement strategies listed above, when funded sufficiently, can achieve equitable enrollment of BIPOC people in clinical trials. “The equitable inclusion of racial and ethnic minorities in clinical trials is possible.  Effectively addressing the relative absence of racial and ethnic minority individuals in clinical trials requires sufficient resources and an ongoing and intentional commitment to meaningfully engaging communities throughout the research process,” the authors said. However, despite this success, White enrollment continues to outpace BIPOC enrollment, highlighting the need for establishing recruitment goals that reserve space for BIPOC persons to enroll in clinical trials. Going forward, population-specific clinical trials, combined with ongoing commitment to BIPOC inclusion initiatives, will strengthen relationships between scientists and underserved communities and decrease health inequities. The authors are specifically interested in how “policy and funding decisions ensure that clinical trialists have the resources, capacity, and requisite skills to ensure equitable inclusion in US-based clinical trials” and how the “community engagement approach used by the CoVPN [can] be replicated by other researchers (individuals and/or networks) across a range of health conditions.”

Andrasik MP, Broder GB, Wallace SE, Chaturvedi R, Michael NL, Bock S, et al. (2021) Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment. PLoS ONE 16(10): e0258858. 10.1371/journal.pone.0258858

This work was supported by the National Institutes of Health COVID-19 Prevention Network.

UW/Fred Hutch Cancer Consortium member Jim Kublin contributed to this work.