Statistical Monitoring of Safety in Clinical Trials

Appropriate monitoring of safety data during the conduct of a clinical trial can ensure timely alteration or termination of the trial to protect patients from potentially harmful treatment. Quantitative evaluation in safety monitoring is important for the study team and the data monitoring committee to make timely recommendations. This article provides an overview of statistical methods for monitoring a prespecified adverse event of interest in a single-arm or controlled clinical trial, including those described in the literature and two proposed methods following a general Bayesian framework using conjugate families. The implementation of statistical methods on safety monitoring is illustrated through clinical trial examples. Practical challenges and considerations are also discussed via simulation studies.