Bioequivalence and Bioavailability Forum • two-stage design power 90% second stage

two-stage design power 90% second stage [Two-Stage / GS Designs]

posted by Yvonne – 2012-08-02 13:47 (4707 d 05:50 ago) – Posting: # 9022
Views: 15,061

Thank you very much for your answer.

❝ You probably need to prove that the overall alpha is preserved under or at 0.05. A simulation study is recommended for this purpose.

I am not very familiar with simulations. I can uderstand that this is very complicated and might take long.

So in practice there are 2 (or 3) possibilities?
option a: a simulation is not that difficult and can be done relatively "easy" with some help (and of course accepted by authorities :-D

). Then I think that this one is prefered

option b: simulations are relatively difficult and without knowing what will happen with the inflation of alpha, the only power that will be accepted by the authorities is 80%

or option c: simulations are relatively difficult but authorites will accept also sample size calculation in the second stage with 90% power (which I hope is the answer :-)

).

Can you or someone else help me with this?

Kind regards,

Yvonne

Complete thread:

two-stage design power 90% second stage Yvonne 2012-08-02 09:50
- two-stage design power 90% second stage ElMaestro 2012-08-02 10:17
  - two-stage design power 90% second stageYvonne 2012-08-02 11:47
    - two-stage design power 90% second stage ElMaestro 2012-08-02 11:54
- two-stage design power 90% in sample size adaption d_labes 2012-08-02 10:33
  - two-stage design power 90% in sample size adaption ElMaestro 2012-08-02 11:29
    - two-stage design power 90% in sample size adaption Yvonne 2012-08-02 12:06
      - two-stage design power 90% in sample size adaption ElMaestro 2012-08-02 16:59
- Are simulations sufficient? …lenghty post! Helmut 2012-08-02 17:39
  - adjusted alpha = 0.045 d_labes 2012-08-03 11:33
    - adjusted alpha = 0.038 Helmut 2012-08-03 14:26
      - adjusted alpha by sims? d_labes 2012-08-03 15:48
        
        Yeah but, no but, yeah but, no but… Helmut 2012-08-03 16:39
        
        Yeah but, no but ... d_labes 2012-08-07 14:42
        
        Yeah but, no but ... Helmut 2012-08-07 15:14