ABSTRACT
This chapter discusses the challenges related to safety evaluation and share people's thoughts on how to apply statistical thinking and methodologies to enhance the collection, analysis, reporting, and interpretation of safety data. It describes the program-wide safety analysis plan and the statistical analysis plan for the integrated summary of safety, documents which summarize the safety analyses to be conducted for the entire clinical development program, and outlines the responsibilities of the data monitoring committee. The chapter discusses adverse events monitoring, highlighting differences in approach between phase II and III. It provides an overview of safety reporting, including subgroup analysis and meta-analysis. A data monitoring committee is established primarily to protect the well-being of the trial participants through periodic review of safety outcomes for an ongoing trial. The goal of a phase II oncology clinical study is to gain preliminary insights into the clinical activity of a novel treatment regimen.
