Bioequivalence and Bioavailability Forum

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

posted by Yvonne – 2012-08-02 13:47 (5081 d 02:13 ago) – Posting: # 9022
Views: 17,849

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 ). 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 / GS Designs] 
  • 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