Otitis Media Trial Publication After ClinicalTrials.gov Registration

Area of Science:

• Otolaryngology
• Clinical Trials Research
• Medical Informatics

Background:

• Otitis media (OM) is a common childhood illness with significant public health implications.
• Clinical trial data is crucial for advancing OM therapies and understanding treatment efficacy.
• Publication bias can skew the perceived success and safety of medical interventions.

Purpose of the Study:

• To determine the publication rate of completed otitis media (OM) clinical trials registered on ClinicalTrials.gov.
• To identify factors associated with the nonpublication of OM clinical trials.

Main Methods:

• A cross-sectional observational study analyzed completed OM trials registered before January 1, 2022.
• Trials were categorized by intervention type, sponsorship, phase, age group, and investigator location.
• Publication status was assessed via systematic searches of ClinicalTrials.gov, PubMed, and Google Scholar, with multivariable logistic regression used to identify predictors of publication.

Main Results:

• Only 18.4% of 256 completed OM trials were published.
• Biologic trials, particularly those for pneumococcal conjugate vaccines (PCVs), had the highest publication rate (81.3%).
• Interventional, biologic, and child-focused trials were significantly more likely to be published than observational, drug, device, procedure, or adult-only trials.

Conclusions:

• The publication rate for OM clinical trials is substantially lower than in other otolaryngology subspecialties.
• While PCV trials demonstrate high publication rates, most other OM trial categories lag significantly.
• Increased investment across the research pipeline is essential to foster innovation in otitis media therapeutics.