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. Ethn Dis. 2020;30(3):429-432; doi:10.18865/ed.30.3.429