Group sequential clinical trial designs for normally distributed outcome variables
Michael J. Grayling
Hub for Trials Methodology Research
MRC Biostatistics Unit
Cambridge, UK
[email protected]
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James M. S. Wason
Hub for Trials Methodology Research
MRC Biostatistics Unit
Cambridge, UK
[email protected]
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Adrian P. Mander
Hub for Trials Methodology Research
MRC Biostatistics Unit
Cambridge, UK
[email protected]
|
Abstract. In a group sequential clinical trial, accumulated data are analyzed at
numerous time points to allow early decisions about a hypothesis of interest. These
designs have historically been recommended for their ethical, administrative, and
economic benefits. In this article, we first discuss a collection of new commands
for computing the stopping boundaries and required group size of various classical
group sequential designs, assuming a normally distributed outcome variable.
Then, we demonstrate how the performance of several designs can be compared
graphically.
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Michael J. Grayling, James M. S. Wason, Adrian P. Mander
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doubletriangular, haybittlepeto, innerwedge, powerfamily, triangular, wangtsiatis, clinical trial design, group sequential
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