Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices.

Abstract

Comprehensible reporting of clinical trial safety data is essential for multiple stakeholders, including ongoing safety reporting by sponsors to the health authorities. However, the consistency and completeness of information about safety events of interest (EOIs) in public sources is not well characterized. This study examined the availability and transparency of adverse event (AE) information from public clinical trial data sources, with a focus on their utility in similar patient populations