group sequential design basics with application … group sequential design basics with application...

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Group Sequential Design Basics with Application Using the

gsDesign R package and its GUI

Keaven M. Anderson

Merck Research Laboratories

February 23, 2011

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Software installation

• R 2.11 – gsDesignExplorer not yet compiled for R 2.12

• gsDesign 2.4-01 from CRAN

• gsDesignExplorer from Biopharmnet– Rename to gsDesignExplorer_1.0-2.zip prior

to installing as an R package from a local zip file

– There is also a version for R 2.9• Rename to gsDesignExplorer_1.0-2.zip, as above

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gsDesignExplorer:Demo for Group Sequential Design with a Time-to-Event

Endpoint

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Summary

• Basic group sequential design theory

• gsDesign R package for deriving group

sequential designs

• gsDesignExplorer GUI interface

• Application to binomial and time-to-event

endpoints

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