• J Biopharm Stat · Jan 2014

    Designing multiregional trials under the discrete random effects model.

    • K-K Gordon Lan, José Pinheiro, and Fei Chen.
    • a Quantitative Decision Strategies , Janssen Research & Development , Raritan , New Jersey , USA.
    • J Biopharm Stat. 2014 Jan 1;24(2):415-28.

    AbstractA discrete random effects model (Lan and Pinheiro, 2012) was proposed recently for multiregional clinical trials for continuous responses. This article elucidates further the application of this model to time-to-event and binary responses. We provide some guidelines on how to design multiregional trials and also show how the same model lends itself naturally to meta-analysis.

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