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

posted by ElMaestro  – Denmark, 2015-04-06 08:53 (2480 d 02:04 ago) – Posting: # 14661
Views: 14,829

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.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,831 posts in 4,567 threads, 1,553 registered users;
online 7 (0 registered, 7 guests [including 1 identified bots]).
Forum time: Wednesday 09:57 CET (Europe/Vienna)

Research under a paradigm must be a particularly effective way
of inducing paradigm change.    Thomas S. Kuhn

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