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Nonbinding futility rule [Two-Stage / GS Designs]

posted by d_labes - Berlin, Germany, 2018-06-13 16:59  - Posting: # 18900
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Dear Ben,

» General remark here: In your example we see that BE has not been achieved only marginally. The Repeated CI is (0.79215, 0.99993). Even though the power of stage 1 is large enough so that we formally conclude futility, one could question whether it is really a good idea to stop the trial due to futility ...

If I see it correctly that's called in Maurer et al. "futility rule can be applied in a nonbinding manner, ie, it can be used as guidance but must not necessarily be followed." (page 19, bottom)
How to obtain a sample size number for the second stage if we want to do so?

Regards,

Detlew

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