Pediatric Acute Otitis Media Clinical Trials: An Analysis of Diversity.

Abstract

This study aims to assess the diversity and equity of pediatric acute otitis media (AOM) trials using ClinicalTrials.gov, focusing on participant demographics and representation to identify gaps in inclusivity and inform strategies for promoting diversity in future pediatric AOM studies. Retrospective analysis. ClinicalTrials.gov. A retrospective analysis was performed on completed clinical trials enrolling pediatric patients with AOM, registered to ClinicalTrials.gov. Only trials that reported results were included. There were 48 trials, excluding duplicates, that matched these criteria. These trials were analyzed for data including study demographics (age, sex, race, ethnicity) and trial characteristics (location, sponsor/funder). The analysis revealed that of the 48 trials, a significant portion underreported race and ethnicity, with 43.7% of trials reporting race and 25% reporting ethnicity. A majority of the participants identified as white (69.9%), showcasing notable disparities in representation. Domestic trials were more likely to report on race (50%) and ethnicity (30%) compared to international trials (22.3% and 0%, respectively). Privately funded trials reported at higher rates (53.3%) compared to publicly funded ones (38.9%), while the reporting of ethnicity was comparably low between both (20% and 33.3%, respectively). The study highlights the urgent need for more inclusive representation in pediatric clinical research, particularly in AOM trials. Despite guidelines aimed at improving demographic reporting, significant gaps remain. Future research efforts must prioritize the inclusion of diverse populations to ensure clinical trials are generalizable and equitable, thereby advancing toward developing more effective and universally applicable health care solutions for pediatric AOM.