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

Author

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  • Yunxia Sui

    (AbbVie Inc)

  • Ruofei Zhao

    (University of Michigan)

  • Yihan Li

    (AbbVie Inc)

  • Xin Wang

    (AbbVie Inc)

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.

Suggested Citation

  • Yunxia Sui & Ruofei Zhao & Yihan Li & Xin Wang, 2022. "Exposure Adjusted Incidence Rate and Event Rate in Clinical Trials with Treatment Crossover," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 14(1), pages 66-78, April.
    • Handle: RePEc:spr:stabio:v:14:y:2022:i:1:d:10.1007_s12561-021-09314-6
    DOI: 10.1007/s12561-021-09314-6
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    References listed on IDEAS

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