Hybrid B/C [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2019-09-18 17:09  – Posting: # 20612
Views: 1,495

Dear Mikalai,

» What prevents us from evaluating the bioequivalence at α-level of 5% as the first step, and if we pass the bioequivalence criteria, we stop the trial. If we fail, we then evaluate the power. If power is more than 80% for the failed parameter, we stop the trial and we are done. If power is less than 80% for the failed parameter, then we go the next stage and adust α-level correspondingly to preserve overall α-level at 0,5. Of course, this should be written in the protocol and is a deviation, maybe a big one, from Potvin C method.

That’s more or less a hybrid of Method C (where you asses power first) and Method B (where you assess power after). You are free to develop such a method but have to validate it (i.e., find a suitable adjusted α which controls the type I error in every possible combination of n1/CV).

Cheers,
Helmut Schütz
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