Safety reporting in trials on glaucoma interventions registered in ClinicalTrials.gov and corresponding publications

Abstract

Abstract Accurate, comprehensive, and consistent reporting of adverse events is of great importance for treatment decisions in clinical practice and patient safety. Aiming to evaluate the completeness and transparency of reported adverse events we conducted a retrospective analysis of completed clinical trials on glaucoma interventions registered in ClinicalTrials.gov from September 27, 2009, and updated and with results on or before November 1, 2023, as well as in corresponding journal publications. Any difference in completeness, number, or terminology/description of adverse events and all-cause mortality between ClinicalTrials.gov and the publication was categorized as inconsistent reporting of adverse events. All 79 trials with results both in the registry and a journal publication exhibited at least one inconsistency in reporting adverse events. In 19 publications (24%), the number of serious adverse events was smaller than in the registry. 69 (87%) trials reported more other adverse events in the registry than in the publication. Trials completed after the FDAA mandate for summary reporting of all-cause mortality more often reported this item in the registry but not in the publication. Trials on glaucoma interventions do not consistently report adverse events and thus introduce concerns about study credibility and potential harms of the interventions. Journals and other stakeholders in trial reporting must address this problem to ensure the safety of patients and trust in health interventions.

Keywords

• Glaucoma treatment
• Reporting
• Adverse event
• Harms
• Safety
• ClinicalTrials.gov