Does unequal alpha distribution make sense? [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2015-05-29 11:31 (3678 d 12:19 ago) – Posting: # 14882
Views: 20,941

Hi Dr_Dan,

❝ Stage I:  0.001 leading to 99.8% CI

❝ Stage II: 0.0413 leading to 9?.?% CI ???


It is generally a 1-2*alpha confidence interval so in this case the coverage is 91.74%.

❝ For the sample size calculation for the second stage you use the GMR 0.95 or the GMR as calculated from stage I results?


So far no method has been published where the observed GMR can be used and where power is not suffering and/or sample size going through the roof. And equally troubling noone has published the proof that using the observed GMR doesn't work. I know at least three different groups of researchers (or two groups and one individual) have been looking at it. I think it is a matter of journals not wishing to publish negative results. Lack of these publications have already caused a few projects to fail as far as I know.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
240 visitors (0 registered, 240 guests [including 32 identified bots]).
Forum time: 23:51 CEST (Europe/Vienna)

Reach for the stars,
even if you have to stand on a cactus.    Susan Longacre

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