Replicated 4×2 and two-stage-design, in the same pro­to­col [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2015-04-06 08:53 (1953 d 15:46 ago) – Posting: # 14661
Views: 14,032

Hi Mauricio,

» Is it possible? Or I am crazy in front of the statistic and statisticians?:confused:

Combining 2-stage and replicated studies in one protocol is hitherto undescribed in the scientific literature. So you likely do not know how the type I error is controlled or how your method performs in terms of power/sample sizes. If the agency asks you to give proof that the Type I Error is controlled you might be somewhat doomed?

There appears to me to be no reason why it wouldn't work, though. It just needs to be investigated and reported.

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

 Admin contact
20,996 posts in 4,377 threads, 1,460 registered users;
online 10 (0 registered, 10 guests [including 8 identified bots]).
Forum time: Tuesday 00:39 CEST (Europe/Vienna)

Average a left-hander with a right-hander
and what do you get?    Donald Norman

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