T1E after 1st stage in Power2Stage [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2022-06-25 00:55 (522 d 20:42 ago) – Posting: # 23085
Views: 1,532

Hi mittyri,

❝ yep, I should reformulate: T1E for the adaptive study finished after 1st stage due to BE goal reached (or some other reason to stop)


See my answer above. It does not change regardless of whether you stopped after stage 1, regardless of whether alpha 1 and alpha 2 are the same or different.

A relevant perspective: Imagine you do a normal trial with a 90% CI of 88.88%-99.99%. What is the type I error? The answer is 5%.
That answer -the 5% percent- does not in any way depend on the figures. Same for the two-stage approach. The type 1 error does not change with your data, it doesn't matter if you stop at stage 1 or not.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,640 registered users;
25 visitors (0 registered, 25 guests [including 15 identified bots]).
Forum time: 20:38 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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