Loss of power etc. [Design Issues]

posted by Astea – Russia, 2016-03-29 01:57 (3242 d 04:29 ago) – Posting: # 16150
Views: 23,636

Dear all!

I understand clear that post-hoc power is set yours teeth on edge, but I'll take a chance to ask a question once more... There was a study with one drop-out. The results of that subject have not been included in the calculation. Recently the customers received a reply from regulatories to calculate aposteriory power and in the case of insufficient power present a plan for further clinical development of the drug.

I estimated power with the help of power.TOST, based on obtained GMR and CV. The result is: power is less than 80% for AUC and more than 80% for Cmax. I remade the calculation including the drop-out: power for AUC is still less than 80%!

Funny thing, but the drugs were bioequivalent! Moreover they are bioequivalent nevetherless including drop-out's results or not! And that fact was already stated in the report. What to do in such a situation? :confused:

"Being in minority, even a minority of one, did not make you mad"

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