Clinical Trial Participation and COVID-19: a Descriptive Analysis from the American Heart Association’s Get With The Guidelines Registry

Abstract

As COVID-19 cases begin to decrease in the USA, learning from the pandemic experience will provide insights regarding disparities of care delivery. We sought to determine if specific populations hospitalized with COVID-19 are equally likely to be enrolled in clinical trials. We examined patients hospitalized with COVID-19 at centers participating in the American Heart Association’s COVID-19 CVD Registry. The primary outcome was odds of enrollment in a clinical trial, according to sex, race, and ethnicity. Among 14,397 adults hospitalized with COVID-19, 9.5% ( n = 1,377) were enrolled in a clinical trial. The proportion of enrolled patients was the lowest for Black patients (8%); in multivariable analysis, female and Black patients were less likely to be enrolled in a clinical trial related to COVID-19 compared to men and other racial groups, respectively. Determination of specific reasons for the disparities in trial participation related to COVID-19 in these populations should be further investigated.

Lessons From COVID-19 for Pandemic Preparedness: Proceedings From a Multistakeholder Think Tank

“…The United States led the world in COVID-19 cases and mortality but not in clinical trial enrollment and development of clinical evidence. Estimates suggest that <10% of hospitalized patients in the United States participated in clinical trials for COVID-19 [ 5 ]. Globally, only 5% of trials were adequately randomized and powered, representing 26% of patient enrollment [ 2 ].…”