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1 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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Page 1: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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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

Page 2: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 3: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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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

Page 4: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 6: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 7: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 8: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 9: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 10: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 12: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 13: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 17: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 18: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 20: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 21: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 22: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 24: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 25: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 26: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 27: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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Page 36: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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

Endpoint

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Page 38: Group Sequential Design Basics with Application … Group Sequential Design Basics with Application Using the gsDesign R package and its GUI Keaven M. Anderson Merck Research Laboratories

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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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