There has been growing awareness of the importance of the statistical evaluation of drug safety data both in the premarketing and postmarketing settings. Careful and comprehensive approaches are warranted in safety evaluation. This paper offers a high-level review of some key issues and emerging statistical methodological developments. Specifically, the following topics are discussed: prospective program-level safety planning, evaluation, and reporting; the impact of adverse event grouping on statistical analysis; the applications of Bayesian methods in safety signal detection; meta-analysis for analyzing safety data; and safety graphics. Aspects related to benefit-risk assessments are also covered.
Keywords: Bayesian methods; PSAP; adverse event grouping; benefit-risk assessment; meta-analysis; safety graphics; signal detection.