Abstract
BACKGROUND: The existing data on enrollment trends of historically underserved racial and ethnic children in clinical trials are limited. OBJECTIVE: We sought to evaluate documentation and representation of race and ethnicity in pediatric asthma clinical trials in the United States. METHODS: This is a cross-sectional study of United States-based interventional trials studying pediatric asthma that were completed between 2008 and 2022 and registered on ClinicalTrials.gov. Enrollment disparities were assessed by using the measure enrollment prevalence difference (EPD) (defined as the median difference between the proportion of participants enrolled and asthma prevalence in the US population by race and ethnicity). RESULTS: Of the 67 trials reviewed, 53 (79.2%) and 36 (53.7%) reported on race and ethnicity at ClinicalTrials.gov, respectively. Most participants were White (39.1%), Black (37.1%), or non-Hispanic (66.1%). Black, Hispanic, multiracial, and White children were enrolled in the expected proportions based on their contribution to asthma burden. However, American Indian or Alaska Native (AI/AN) (EPD = -1 [95% CI = -1 to -1]) and Asian children (EPD = -3 [95% CI = -3 to -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 to -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 to -1.19]). CONCLUSIONS: Enrollment in pediatric asthma trials conducted in the United States was commensurate with the demographics of children affected by asthma for most racial and ethnic groups, but American Indian or Alaska Native and Asian children were underrepresented. Concerted efforts are needed to promote inclusion of these underserved groups in future trials.