(1011) Determinants of Trial Viability and Results Dissemination in Otitis Media: A Registry Analysis

Introduction: Despite the high prevalence of otitis media (OM), the research landscape is compromised by frequent early study cessation and a failure to disseminate findings. This study analyzes the ClinicalTrials.gov registry to quantify these evidence gaps and identify specific predictors of trial discontinuation and non-reporting.

Methods: A retrospective analysis of ClinicalTrials.gov for all registered interventional and observational OM studies was performed from inception to January 1, 2026. Trials were stratified by recruitment status (completed vs. terminated/withdrawn) and posted results. Predictors of trial completion—including funding source, design, intervention, and enrollment—were evaluated using Chi-square and Mann-Whitney U tests (P < 0.05).

Results: Of the 217 OM trials analyzed, 85.3% (n=185) completed; 14.7% (n=32) discontinued. Subject accrual determined viability; completed studies enrolled a median of 120 vs 10 subjects in the discontinued cohort (P < 0.00001). Trials enrolling ≥25 participants achieved 92.3% completion vs 48.5% for those below the threshold. Vaccine trials showed highest completion (94.7%), outperforming drug (85.5%) and device (82.1%). Only 30.4% (n=66) publicly reported results. Industry trials were significantly more likely to report findings than academic institutions (P=0.0042). Paradoxically, randomized trials were less likely to post results than non-randomized designs (P < 0.00001).

Conclusions: The integrity of otitis media research is compromised by two distinct failure points: the inability to recruit sufficient patient cohorts for trial completion and the subsequent failure to disseminate findings. While enrollment volume predicts viability, the underreporting of results, particularly among academically funded trials, suggests a need for systemic reform. Future research policies must incentivize multi-center collaboration to ensure recruitment targets are met while simultaneously enforcing data transparency to prevent research waste.