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. 2021 Oct 19;16(10):e0258858.
doi: 10.1371/journal.pone.0258858. eCollection 2021.

Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment

Michele P Andrasik  1 , Gail B Broder  1 , Stephaun E Wallace  1 , Richa Chaturvedi  2 , Nelson L Michael  3 , Sally Bock  4 , Chris Beyrer  5 , Linda Oseso  1 , Jasmin Aina  1 , Jonathan Lucas  6 , David R Wilson  7 , James G Kublin  1 , George A Mensah  8
Affiliations

Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment

Michele P Andrasik et al. PLoS One. .

Abstract

Longstanding social and economic inequities elevate health risks and vulnerabilities for Black, Indigenous and People of Color (BIPOC) communities. Engagement of BIPOC communities in infectious disease research is a critical component in efforts to increase vaccine confidence, acceptability, and uptake of future approved products. Recent data highlight the relative absence of BIPOC communities in vaccine clinical trials. Intentional and effective community engagement methods are needed to improve BIPOC inclusion. We describe the methods utilized for the successful enrollment of BIPOC participants in the U.S. Government (USG)-funded COVID-19 Prevention Network (CoVPN)-sponsored vaccine efficacy trials and analyze the demographic and enrollment data across the efficacy trials to inform future efforts to ensure inclusive participation. Across the four USG-funded COVID-19 vaccine clinical trials for which data are available, 47% of participants enrolled at CoVPN sites in the US 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. Despite robust fiscal resources and a longstanding collaborative and collective effort, enrollment of White persons outpaced that of BIPOC communities. With appropriate resources, commitment and community engagement expertise, the equitable enrollment of BIPOC individuals can be achieved. To ensure this goal, intentional efforts are needed, including an emphasis on diversity of enrollment in clinical trials, establishment of enrollment goals, ongoing robust community engagement, conducting population-specific trials, and research to inform best practices.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. US diverse enrollment across the NIH-funded Moderna, AstraZeneca, J&J, and Novavax trials.
Fig 2
Fig 2. Moderna (Cove study) enrollment.
(A) Counts reflect randomized participants.
Fig 3
Fig 3. AstraZeneca study enrollment.
(A) Counts reflect randomized participants.
Fig 4
Fig 4. J&J (ensemble study) enrollment.
(A) Counts reflect participants who completed study Day 1 with the intention of continuing.
Fig 5
Fig 5. Novavax study enrollment.
(A) Counts reflect participants who completed study visit 2 or 2.1.
See this image and copyright information in PMC

References

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