Sequential trial with B method of Potvin [Two-Stage / GS Designs]

posted by john john – Spain, 2015-10-01 19:44 (3419 d 00:13 ago) – Posting: # 15513
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In a sequential clinical trial conducted like a B method of Potvin, we have Cmax and AUC both not bioequivalent. Cmax has a power <80% (71.5%), and AUC>80% (84.6%).
AUC 0-30min calculated by protocol is bioequivalent.
In the protocol it was not specified how to proceed in this situation.

Can we calculate a new n and pass to the second phase? Or we must stop the trial?

Thanks


Edit: Category changed. [Helmut]

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