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An overview of group sequential methods in longitudinal clinical trials

Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaèl, Leuven, Belgium, bart.spiessens{at}med.kuleuven.ac.be

Emmanuel Lesaffre

Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaèl, Leuven, Belgium

Geert Verbeke

Biostatistical Center, Catholic University of Leuven, U.Z. St.-Rafaël, Leuven, Belgium

KyungMann Kim

Department of Biostatistics and Medical Informatics, University of Wisconsin, Clinical Science Center, Madison, Wisconsin, USA

David L DeMets

Department of Biostatistics and Medical Informatics, University of Wisconsin, Clinical Science Center, Madison, Wisconsin, USA

During the last decade, several papers have been published on group sequential methods in general and on sequential longitudinal clinical trials in particular. This paper gives an overview of the proposed methods, emphasizing longitudinal clinical trials. Furthermore, it tries to answer some practical questions that may arise during the conduct of interim analyses in longitudinal trials. Simulations have been carried out to obtain insight in these practical considerations.

Statistical Methods in Medical Research, Vol. 9, No. 5, 497-515 (2000)
DOI: 10.1177/096228020000900506


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