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Planning and core analyses for periodic aggregate safety data reviews
H Amy Xia1, Brenda J Crowe, Robert C Schriver
1Amgen, Inc., Thousand Oaks, CA, USA.
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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