Planning and core analyses for periodic aggregate safety data reviews

Abstract

Background In 2009, the Safety Planning, Evaluation and Reporting Team gave detailed recommendations for a well-planned and systematic approach for safety data collection and analysis. Important aspects of this approach included regular reviews of aggregate data by a multidisciplinary team focusing on safety.

Purpose This article provides information to facilitate the planning and implementation of aggregate data reviews.

Methods Our recommendations are based on experience of the authors and review of relevant literature.

Results We present information regarding the planning of aggregate data reviews as well as examples of data displays that are useful for many different compounds. A subset of these data displays could form a set of ‘core’ analyses to be generated for aggregate data reviews.

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