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Abstract:
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There has been a growing awareness of importance relative to statistical evaluation of drug safety data recently. The use of statistics in assessing clinical trial safety data is important and often needs additional consideration. Some key problems in safety analyses will be highlighted. Some of the emerging statistical methodology developments in this area will be discussed, such as the application of the Bayesian hierarchical modeling of clinical trial safety data to address multiplicity issues, metaanalysis techniques for analyzing rare adverse events data, and some graphical advances in mining safety data. In addition, issues with evaluation of aggregate data for understanding the evolving safety profile, and especially for detecting potential safety signals during the course of clinical trials in drug development, will be discussed.
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