Impact of COVID-19 on clinical research and inclusion of diverse populations

Abstract

The randomized clinical trial (RCT) has long been recognized as the 'gold standard' for developing evidence for clinical treatments and vaccines; however, the successful implementation and translation of these findings is predicated upon external validity. The generalization of RCT findings are jeopardized by the lack of participation of at-risk groups such as African Americans, with long-recognized disproportional representation. Distinct factors that deter participation in RCTs include distrust, access, recruitment strategies, perceptions of research, and socioeconomic factors. While strategies have been implemented to improve external validity with greater participation among all segments of the population in RCTs, the coronavirus disease 2019 (COVID-19) pandemic may exacerbate disparities in RCT participation with the potential impact of delaying treatment development and vaccine interventions that are applicable and generalizable. Thus, it is essential to include diverse populations in such strategies and RCTs. This Perspective aims to direct attention to the additional harm from the pandemic as well as a refocus on the unresolved lack of inclusion of diverse populations in conducting RCTs.