Integrated Safety Analysis: Statistical Issues in the Assessment of Safety in Clinical Trials

The emphasis in this essay will be on statistical issues in the assessment of safety, and in particular, in putting these issues in context. The present status and future goals for the assessment of safety will be considered. This can only be understood in the context of the medical, biological, and economic setting of the future.

In the words of an ancient Oriental proverb: “If you don't know where you're going, it's hard to plan the route.” To this end, the reader is mentally asked to jump ahead and to envision the world in the year 2015.