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An Approach to Integrated Safety Analyses From Clinical Studies

Title
An Approach to Integrated Safety Analyses From Clinical Studies

Abstract
The analysis of safety data of clinical studies poses specific problems that are related to a multiplicity of usually not explicitly specified hypotheses. Furthermore, individual studies are generally not capable of providing a comprehensive picture of the safety profile of a drug. Therefore, data from different studies have to be combined to reach conclusions. Based on a generalized linear mixed effects model, I present an approach that can address both aspects under plausible assumptions. The method is applied to a real example.