Science fiction [Two-Stage / GS Designs]

posted by Dr_Dan  – 2016-03-04 10:33 (1891 d 22:14 ago) – Posting: # 16048
Views: 12,766

Dear all
nearly one year ago ElMaestro wrote:

» 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

and Helmut:

» A lot of problems. I agree with ElMaestro.
» » Is it possible?
» Not yet – unless you have access to a massive-parallel supercomputer... I made a quick estimation (I have a very fast workstation): ~60 years running 24/7…

My question for today: is this still the case/state of science that you can not combine 2-stage and replicate designs?
A short update would be very much apreciated. In case that there is new literature available I would love if you could give references.
Thanks for your comments in advance.
Kind regards

Kind regards and have a nice day

Complete thread:

 Admin contact
21,445 posts in 4,482 threads, 1,510 registered users;
online 15 (0 registered, 15 guests [including 2 identified bots]).
Forum time: Sunday 09:48 CEST (Europe/Vienna)

It is better to know some of the questions
than all of the answers.    James Thurber

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