Enrollment of underserved racial and ethnic populations in pediatric asthma clinical trials

Abstract

BackgroundLimited data exist on enrollment trends of historically underserved racial and ethnic children in clinical trials. ObjectiveWe sought to evaluate documentation and representation of race and ethnicity in pediatric asthma clinical trials in the US. MethodsThis is a cross-sectional study of US-based interventional trials studying pediatric asthma completed between 2008 and 2022 and registered on ClinicalTrials.gov. Enrollment disparities were assessed using the enrollment prevalence difference (EPD) measure – the median difference between the proportion of participants enrolled and asthma prevalence in the US population by race and ethnicity. ResultsOf the 67 trials reviewed, 53 (79.2%) and 36 (53.7%) reported on race and ethnicity in ClinicalTrials.gov, respectively. Most participants were White (39.1%), Black (37.1%), and non-Hispanic (66.1%). Black, Hispanic, Multiracial, and White children were enrolled in expected proportions based on their contribution to asthma burden. However, American Indian or Alaska Native (AI/AN) (EPD: -1, 95% CI: -1, -1) and Asian children (EPD: -3, 95% CI: -3, -3) were underrepresented, relative to disease burden in these respective groups. Fewer Black children were enrolled in drug or device trials (β=-0.80; 95% CI -1.60, -0.01) than in other trials. Fewer Hispanic children were enrolled in early phase than late phase trials (β=-2.42; 95% CI -3.66, -1.19). ConclusionsEnrollment in pediatric asthma trials conducted in the US was commensurate with the demographics of children affected by asthma for most racial and ethnic groups, but AI/AN and Asian children were underrepresented. Concerted efforts are needed to promote inclusion of these underserved groups in future trials.