Systematic review with cross sectional comparative analysis identifies adverse event reporting discrepancies between...

Glaucoma is a leading cause of irreversible blindness worldwide. As new treatments emerge, transparent reporting of adverse events (AEs) in clinical trials is essential to ensure patient safety. However, discrepancies persist in the reporting of serious adverse events (SAEs), other adverse events (OAEs), mortality, and participant withdrawals between clinical trial registries and their corresponding peer-reviewed publications. In this systematic review with a cross-sectional comparative analysis, we searched ClinicalTrials.gov for completed glaucoma randomized controlled trials (RCTs) and matched each record to its corresponding publication by screening PubMed and Google Scholar (27 September 2009-31 December 2024). Data on SAEs, OAEs, mortality, and participant withdrawals were compared between registry entries and corresponding journal publications. Statistical analyses assessed the extent and significance of discrepancies. Among 57 eligible trials, 31.6% showed discrepancies in SAE reporting (p < 0.05), and 77.2% had discrepancies in OAE reporting (p < 0.05), with publications frequently omitting key safety data. Mortality reporting was reported in 61.4% in ClinicalTrials.gov compared to 42.1% in published papers and mortality discrepancies were observed in 47.4% of trials. These findings confirm widespread underreporting or omission of safety data in published literature, raising transparency and ethical concerns. To improve AE reporting accuracy, we recommend stricter journal oversight, enforcement of CONSORT-harms guidelines, and broader adoption of supplementary materials for comprehensive safety data disclosure.