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

posted by ElMaestro  – Denmark, 2015-10-01 19:58 (3101 d 15:59 ago) – Posting: # 15514
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Hi JJ,

❝ 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?


I would go by the metric that displays the highest variance, which is usually Cmax. I suggest to proceed towards stage 2 on that basis.
However, since this was not pre-specified it is your protocol that document may be your biggest issue now; regulators may not like whatever decision you take.

Pass or fail!
ElMaestro

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