Single site? [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2021-01-19 11:32 (111 d 20:40 ago) – Posting: # 22182
Views: 476

Salam alghazam,

» Previous posts and responses on significance of group effect were focusing on the Group*Treatment factor.

Which is crap. See this presentation.

» What is the situation when group term is associated with a p-value of 0.02 …

That’s at least unusual if the the study was performed in multiple groups at one site.
If this was a multi-center study (group = site), it happens more often.

» … and the treatment*group is associated with a p-value of more than 0.35.

Fine, if the study was performed at one site. Acc. to the FDA it will allow you to drop this effect and proceed with ‘Model II’. However, this procedure leads to an inflate Type I Error because you have a pre-test (slides 20–21 of the presentation). Simply use ‘Model II’ with the following effects directly:

PS: I will have a meeting with the FDA (dealing with a multi-site study) in the near future. Will report back how they reacted. ;-)

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,446 posts in 4,483 threads, 1,511 registered users;
online 32 (0 registered, 32 guests [including 11 identified bots]).
Forum time: Tuesday 09:13 CEST (Europe/Vienna)

The fact that some geniuses were laughed at
does not imply that all who are laughed at are geniuses.    Carl Sagan

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