Otitis Media Trial Publication After ClinicalTrials.gov Registration.

Abstract

To evaluate the proportion of completed otitis media (OM) clinical trials registered on ClinicalTrials.gov and identify factors associated with nonpublication. Cross-sectional observational study. ClinicalTrials.gov registry and peer-reviewed literature databases. ClinicalTrials.gov was queried for completed OM-related trials with primary completion dates before January 1, 2022. Trials were categorized by intervention type, sponsorship, phase, age group, and principal investigator location. Publication status was determined through systematic searches of ClinicalTrials.gov, PubMed, and Google Scholar. Multivariable logistic regression identified factors associated with publication. Of 256 completed OM trials, only 18.4% (47) were published. Biologic trials-primarily studies evaluating pneumococcal conjugate vaccines (PCVs)-had the highest proportion published (81.3%), followed by drug trials (20.5%), procedure trials (18.8%), device trials (8.9%), and other trials (8.0%). Interventional trials were more frequently published than observational trials (24.2% vs 2.9%). In multivariable analysis, biologic interventions, interventional study design, and child-focused studies were significant predictors of publication. Drug, device, and procedure trials had significantly lower odds of publication compared to biologics. Adult-only studies and observational trials were also less likely to be published. Fewer than 1 in 5 OM trials were published-a proportion substantially lower than in other otolaryngology subspecialties. While PCV trials had high publication proportions, most other categories lagged. Greater investment across the research pipeline is needed to drive innovation in OM therapy.