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Published on: January 25, 2015
Non-Publication of Interventional Studies for Uveal Melanoma
Fahad R Butt1, Sidrat Rahman2, Thanansayan Dhivagaran1
1Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada.
Introduction:
Evidence-based medicine relies on publicly available research findings, and the non-publication of studies may predispose to incomplete evidence on intervention efficacy or redundant funding for re-attempting unpublished studies. This study investigated non-publication rates among US-registered interventional studies for uveal melanoma.
Methods:
In April 2025, ClinicalTrials.gov was searched for interventional uveal melanoma studies. Interventional studies were included if completed at least 3 years prior to the database search, excluding completed trials awaiting results publication. Studies were labeled as having publicly available results if data were posted through ClinicalTrials.gov or in a journal publication. For published studies, we determined whether their primary study endpoint result was statistically significant. For all records, we collected study characteristics, including phase, sponsor, country of study, year of study initiation, enrollment, melanoma type, treatment type, and randomization status. The primary outcome was the overall rate of non-publication among all records. Second, we provided descriptive characteristics of included records and compared rates of non-publication between sublevels of primary endpoint significance status and study characteristics. Wherever applicable, the Fisher-exact, Wilcox rank-sum, and binomial exact tests analyzed these comparisons. Analysis was completed in RStudio (v2022.02 + 433).
Results:
From 102 records, we identified 98 trials (N = 4,669) for final inclusion. Overall, 38% of records did not have an identifiable online publication on any platform. Whether published or unpublished, 23% and 16% of trials were terminated, respectively, and the reasons for termination were heterogeneous. Trials with industry sponsorship were significantly more often published than those without industry sponsorship (p = 0.024). No significant association was found between publication status and study phase, enrollment size, study duration, or randomization status. Among the 60 studies published online, 64% had reported significant primary study endpoints. Given this, the calculated probability of publication to ClinicalTrials.gov or in a journal was 65% [95% CI: 51.60-76.87%; p = 0.03]. No significant association was found between significant positive primary outcome results and randomization status or sponsor type.
Conclusion:
About one-third of US-registered uveal melanoma interventional studies were not published online. Greater transparency of results or reasons for non-publication is needed.
