A comparison of group sequential methods for binary longitudinal data

Authors

  • Bart Spiessens,

    1. Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaël, Kapucijnenvoer 35, B-3000 Leuven, Belgium
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  • Emmanuel Lesaffre,

    Corresponding author
    1. Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaël, Kapucijnenvoer 35, B-3000 Leuven, Belgium
    • Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaël, Kapucijnenvoer 35, B-3000 Leuven, Belgium
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  • Geert Verbeke

    1. Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaël, Kapucijnenvoer 35, B-3000 Leuven, Belgium
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Abstract

Interim analyses are conducted to allow for early termination of the trial, for ethical as well as economical reasons. Here we consider interim analyses in repeated measurements studies where the measurements are binary. Two methods for analysing this kind of data are compared according to their operating characteristics. A subject-specific approach based on the logistic random-effects model is compared with the population-averaged approach based on the generalized estimating equations. The comparison is illustrated with simulations using a randomized clinical trial for toenail fungal infection. Copyright © 2003 John Wiley & Sons, Ltd.

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