Exposure Adjusted Incidence Rate and Event Rate in Clinical Trials with Treatment Crossover

Yunxia Sui (), Ruofei Zhao, Yihan Li and Xin Wang
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Yunxia Sui: AbbVie Inc
Ruofei Zhao: University of Michigan
Yihan Li: AbbVie Inc
Xin Wang: AbbVie Inc

Statistics in Biosciences, 2022, vol. 14, issue 1, No 4, 66-78

Abstract: Abstract Exposure adjusted incidence rate (EAIR) and exposure adjusted event rate (EAER) are two commonly used measures for adverse event risk in clinical trials. However, in clinical trials with treatment crossover, classical EAIR and EAER should be adapted before being used due to the presence of within subject correlation. In this paper, we review the definition and motivation of EAIR and EAER, discuss how we can use mixed-effect models and generalized estimating equations to adapt EAIR and EAER to the treatment crossover case, and evaluate the proposed methods on synthetic trial data. We aim to combine both theory and practicality – while presenting sufficient theoretical motivation and justification, we also provide the SAS code for the proposed methods and discuss the practical issues one might encounter when applying them.

Date: 2022
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DOI: 10.1007/s12561-021-09314-6

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