Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

摘要

BackgroundThe quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials.