S1043 Evaluating Publication Imbalances and Key Characteristics in Eosinophilic Esophagitis Clinical Trials: Patterns and Trends

Introduction: Clinical trials publication discrepancies distort the perceived effectiveness of treatments by placing greater emphasis on studies with positive outcomes while underrepresenting negative findings. This study examines patterns in EoE clinical trials (CT), as their characteristics have not been adequately investigated. Methods: Utilizing ClinicalTrials, EoE-registered CT were categorized. To assess publication status, a completion date was set, allowing a 3-year window for publication. We searched for trial publications on ClinicalTrials, PubMed, and Google Scholar. Trials that were deemed statistically significant and achieved their objective were classified as positive studies. For statistical analysis, we performed Fisher’s exact test, t test, and Chi-square tests. Results: There were 196 EoE studies, the majority being interventional (64.80%), of which the majority were in the late phase (59.06%; P < 0.001) and focused on drug treatment (58.27%). Interventional CTs centered on adults (54.33%), while observational CTs included both adults and children (57.97%), P = 0.013. Most trials were led by male principal investigators (PIs) (82.65%) with a medical degree (MD) (76.02%). The majority of CTs were performed in the U.S. (76.38% interventional and 71.01% observational, P = 0.411) and were non-industry funded (64.57% interventional and 92.75% observational, respectively, P < 0.0001). Industry-funded studies were mostly interventional. Interventional trials had a higher completion rate (54.33% vs 43.48%; P = 0.001). Of the 78 completed trials, 56 (71.79%) were published, of which the majority were interventional (75.00%; P = 0.004), in the late phase (51.79%; P = 0.02), and domestic (83.93%; P = 0.822). Among the 56 published trials, 35 (62.5%) had positive outcomes, and 21 (37.5%) had negative outcomes (P = 0.205). Of the publications with positive outcomes, similar percentages were interventional vs observational (59.52% vs 71.43%; P = 0.158). Conclusion: The majority of EoE clinical trials involve adults and were not industry-sponsored. Most industry studies were interventional. Most published trials were led by male MD PIs, reflecting gender disparities in leadership. Finally, the majority of published trials (interventional or observational) report positive results.