Statistical Evaluation of Drug Safety Data

Therapeutic Innovation & Regulatory Science
H Amy Xia, Qi Jiang

Abstract

There has been growing awareness of the importance of the statistical evaluation of drug safety data both in the premarketing and postmarketing settings. Careful and comprehensive approaches are warranted in safety evaluation. This paper offers a high-level review of some key issues and emerging statistical methodological developments. Specifically, the following topics are discussed: prospective program-level safety planning, evaluation, and reporting; the impact of adverse event grouping on statistical analysis; the applications of Bayesian methods in safety signal detection; meta-analysis for analyzing safety data; and safety graphics. Aspects related to benefit-risk assessments are also covered.

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Citations

Feb 13, 2020·Statistics in Medicine·Xianming TanJoseph G Ibrahim
Jan 1, 2014·Therapeutic Innovation & Regulatory Science·J Rick Turner
Mar 2, 2016·Pharmaceutical Statistics·Ralf BenderStefan Lange
Jan 7, 2017·Clinical Trials : Journal of the Society for Clinical Trials·Motoi OdaniTosiya Sato
Nov 10, 2015·Statistics in Biopharmaceutical Research·Janet WittesJudith Kramer
Jul 12, 2018·Therapeutic Innovation & Regulatory Science·Michael W ColopyGreg Ball
Oct 23, 2020·Contemporary Clinical Trials·Yafei ZhangWilliam W B Wang
Mar 24, 2021·Therapeutic Innovation & Regulatory Science·Barbara A HendricksonLothar Tremmel

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