“Group-by-Treatment Interaction” [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2019-07-23 10:32  – Posting: # 20435
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Hi GM,

» I have seen one FDA BE review […].

Yep, the 1999 (!) infamous one. Groups separated by two weeks. See the FDA’ applicable guidance (2001), Section VII.A.

» Here agency is asking for the BE of any one of the group, if group-by-treatment interaction is significant (p<0.05).

0.1 not 0.05. BTW, did you bother reading the presentation I linked in my OP?

» Is it possible in studies conducted on HVD?

Do you have a replicate design in mind? For ABE, no problem. For the EMA’s ABEL, doable. For the FDA’s RSABE, difficult. Ask three statisticians only to get get four options. Possible that the FDA insists on the fifth nobody has thought about. Difficult terrain.

» Please provide your thoughts on the same.

Let’s assume that you plan the study in such a way that groups are not expected to differ (see ElMaestro’s post).Do not (!) apply the framework suggested by the FDA in the dark ages!

Helmut Schütz

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