Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 11:20 (896 d 16:13 ago) – Posting: # 19270
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Hi Gm,

» […] BE study of Highly variable drug in […] 3 groups, which are seperated by one month from each other. There is no clarity in the guidance to check the group effect for this design.

Which agency’s guidance?

» Our doubt is, whether the group effect should be checked in the full replicate design or not?

What do you mean by “checked”? Have group – together with some nested terms – as part of the model (only report the MSEs, p-values) or do you additionally want to base any decision on it? That’s not a good idea, since power might be compromised and the Type I Error inflated (see this presentation).

» If so, what are the fixed/random effets need to be checked in RSABE and ABE?

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