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.
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.
Authors: Janet Wittes; Brenda Crowe; Christy Chuang-Stein; Achim Guettner; David Hall; Qi Jiang; Daniel Odenheimer; H Amy Xia; Judith Kramer Journal: Stat Biopharm Res Date: 2015-10-09 Impact factor: 1.452
Authors: Patrick Archdeacon; Cheryl Grandinetti; José M Vega; David Balderson; Judith M Kramer Journal: Ther Innov Regul Sci Date: 2014-03 Impact factor: 1.778