No – futile! – test for G×T, pleeze… [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2021-04-23 17:14 (1181 d 09:58 ago) – Posting: # 22322
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Hi ElMaestro & PVRC,

❝ If this is a dossier for EU:

❝ 1. If you don't add a group effect, the regulator is likely to ask for it after submission.


Hundreds of studies accepted in the past without one. Seems to become increasingly fashionable recently.

❝ 2. If you do add a group effect, regulators are likely to ask you to submit a secondary analysis without it.

:-D:-D:-D


Xactly. See there.

❝ At the end of the day Group is a between-factor, like sequence. Thus, the discussion is quite academic if we look at the confidence interval.


Yep.

❝ Another matter of course is if we, for some reason or other, take an interest in the p-value of the group effect itself or group x treatment. The latter sends shivers down my spine.


Not even the highest dose of Schützomycin would help.

BTW, last month I endured a ‘Type A Meeting’ for an IND with the FDA.
I proposed to use ‘Model II’ without the stupid pre-test for a G × T interaction in ‘Model I’ because it inflates the Type I Error. Since writing a paper is on my todo-list for more than five years (:waving: Nastia; I’m still collecting data), I was referring to my presentation at BioBridges in Prague 2018 (see esp. the backup-slides). Was accepted. :-D

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