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Abstract

When a new drug is being developed for market approval, clinical trials are intended to assess efficacy and safety. Typically, however, individual trials are designed vis a vis one (or a few) efficacy parameters. This is because there is usually inadequate information to specify the safety endpoints, and to characterize the population at risk. Also, the cost of studying any specific adverse event definitively in a single study is usually prohibitive. Thus, safety information is monitored throughout the efficacy trials and then the safety profile of the new drug is described across trials. The manner in which safety information is collected implies that formal statistical inference is invalid. Several descriptive techniques for displaying safety information accumulated during clinical trials will be presented.

Keywords

Clinical trials Adverse events Safety assessment Descriptive techniques Statistical inference

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Clinical Trial Adverse Events: The Case for Descriptive Techniques

Abstract

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References