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

posted by Helmut Homepage – Vienna, Austria, 2021-04-23 17:14 (588 d 07:32 ago) – Posting: # 22322
Views: 1,580

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

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,424 posts in 4,694 threads, 1,600 registered users;
21 visitors (2 registered, 19 guests [including 8 identified bots]).
Forum time: 23:47 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5