Rejoinder to "Multivariate Bayesian Logistic Regression for Analysis of Clinical Trial Safety Issues"
Rejoinder to "Multivariate Bayesian Logistic Regression for Analysis of Clinical Trial Safety Issues" by W. DuMouchel [arXiv:1210.0385].
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arXiv subjects
William DuMouchel
Publications and source records attributed to William DuMouchel.
Multivariate Bayesian Logistic Regression for Analysis of Clinical Study Safety Issues
This paper describes a method for a model-based analysis of clinical safety data called multivariate Bayesian logistic regression (MBLR). Parallel logistic regression models are fit to a set of medically related issues, or response variables, and MBLR allows information from the different issues to "borrow strength" from each other. The method is especially suited to sparse response data, as often occurs when fine-grained adverse events are collected from subjects in studies sized more for efficacy than for safety investigations. A combined analysis of data from multiple studies can be performed and the method enables a search for vulnerable subgroups based on the covariates in the regression model. An example involving 10 medically related issues from a pool of 8 studies is presented, as well as simulations showing distributional properties of the method.
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