Two stage group sequential, multi site, 2-way crossover BE [Design Issues]

posted by MGR  – India, 2009-02-05 11:32 (6352 d 23:25 ago) – Posting: # 3181
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Dear SKR,

As it is a two stage group sequential design, you may have to go for an alpha spending fuction (likely O'Brien-Fleming method). May be the following links helps you to get an idea on the study design.

http://www.cytel.com/papers/usefun.pdf
http://www.cytel.com/Products/East/example_02.asp#2
http://www3.interscience.wiley.com/journal/113398744/abstract
http://www.biostat.wisc.edu/Clinical_Trials/pdf/ron_talk.pdf
http://www.cytel.com/papers/SymposiumNJ2002.pdf
http://biostat.hitchcock.org/BSR/Analytics/Sequential/SpendingBounds.asp

Note: I am not the expert in this topic, but we have to wait for the comments from the experts.

Thank you,
—
Regards,
MGR

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