The analysis of safety data from clinical trials

Ioannis Papastathopoulos*, Harry Southworth

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter


The analysis of the efficacy of a drug in a clinical trial amounts to quantifying the expected response of patients to the drug. The analysis of safety data, though, amounts to characterizing the unexpected, or extreme, response of a minority of patients. As such, the statistical methods used to analyse efficacy data are inappropriate to the analysis of safety data. We illustrate how univariate and multivariate approaches to the analysis of clinical trial safety data can identify and characterize potential toxicities.

Original languageEnglish
Title of host publicationExtreme Value Modeling and Risk Analysis: Methods and Applications
PublisherCRC Press
Number of pages14
ISBN (Electronic)9781498701310
ISBN (Print)9781498701297
Publication statusPublished - 21 Dec 2015


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