Reporting of participant race and ethnicity from COVID-19 randomized controlled drug and biologicals trials: a scoping review

Abstract

Racial and ethnic minorities have been disproportionally burdened by hospitalization and death due to COVID-19. Participation of individuals of diverse races and ethnicities in clinical trials according to study-level characteristics of randomized controlled trials (RCT) that test effectiveness of COVID-19 drugs could be insightful for future researchers. The objective of this scoping review was to describe frequency of race and ethnicity reported as demographic variables and specific reporting of race and ethnicity according to COVID-19 RCT characteristics. We conducted comprehensive searches in Pubmed, ProQuest, WHO Database, and Cochrane Central Register of Controlled Trials, and gray literature via preprint servers from 1/1/2020 to 5/4/2022. We included RCTs on emergency- or conditionally-approved COVID-19 drug interventions (remdesivir, barcitinib, and molnupiravir) with or without comparators. Self-reported race as American Indian/Pacific Islander, Asian, Black/African American, or White, ethnicity as Hispanic/Latinx, study design characteristics, and participant-relevant data were collected. A total of 17 RCTs with 17935 participants was included. Most (n=13, 76%) reported at least one race and ethnicity and were US-based, industry-funded RCTs. Asian, Black, Latinx, and White participants were mostly enrolled in RCTs that studied remdesivir. Native American and Hawaiian participants were mostly assessed for progression to high-flow oxygen/non-invasive ventilation. Time to recovery was assessed predominantly in Black and White participants, while hospitalization or death was mostly assessed in Asian, Latinx, and multi-race participants. Trialists should be aware of RCT-level factors and characteristics that may be associated with low participation of racial and ethnic minorities, which could inform evidence-based interventions to increase minority participation. Registration: Open Science Framework: https://osf.io/3dx4f/?view_only=d1af00d952cc472b803df5297bce9a80