Bioequivalence and Bioavailability Forum • Science fiction

Science fiction [Two-Stage / GS Designs]

posted by Dr_Dan – Germany, 2016-03-04 11:33 (3757 d 15:25 ago) – Posting: # 16048
Views: 18,774

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
Dr_Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Replicated 4×2 and two-stage-design, in the same protocol Mauricio Sampaio 2015-04-06 08:37 [Two-Stage / GS Designs]
- Replicated 4×2 and two-stage-design, in the same protocol ElMaestro 2015-04-06 08:53
- Science fiction Helmut 2015-04-06 14:20
  - Science fictionDr_Dan 2016-03-04 10:33
    - Science fiction furthermore d_labes 2016-03-04 13:21
    - Still SF Helmut 2016-03-04 13:41
      - Still SF VStus 2016-10-06 21:08
        
        Still SF ElMaestro 2016-10-06 22:13
        
        Still SF VStus 2016-10-06 22:53
        Still SF VStus 2016-10-11 10:23
        
        Still SF Helmut 2016-10-07 10:38
        
        Still SF VStus 2016-10-11 09:10
- mindblowing ElMaestro 2016-10-11 07:44
  - Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50
    - Consistency DavidManteigas 2016-10-11 11:25