Bioequivalence and Bioavailability Forum • Nonbinding futility rule

Nonbinding futility rule [Two-Stage / GS Designs]

posted by d_labes – Berlin, Germany, 2018-06-13 18:59 (2289 d 17:55 ago) – Posting: # 18900
Views: 16,156

Dear Ben,

❝ General remark here: In your example we see that BE has not been achieved only marginally. The Repeated CI is (0.79215, 0.99993). Even though the power of stage 1 is large enough so that we formally conclude futility, one could question whether it is really a good idea to stop the trial due to futility ...

If I see it correctly that's called in Maurer et al. "futility rule can be applied in a nonbinding manner, ie, it can be used as guidance but must not necessarily be followed." (page 19, bottom)
How to obtain a sample size number for the second stage if we want to do so?

—
Regards,

Detlew

Complete thread:

Finally: Exact TSD methods for 2×2 crossover designs Helmut 2018-04-21 17:17 [Two-Stage / GS Designs]
- Exact TSD methods: Example Helmut 2018-04-21 20:33
- Finally: Exact TSD methods for 2×2 crossover designs ElMaestro 2018-04-21 20:49
  - Flow chart (without details) Helmut 2018-04-21 21:41
    - naive questions regarding new functions in Power2Stage mittyri 2018-04-28 15:54
      - Some answers Helmut 2018-04-28 17:29
      - Some more "answers" d_labes 2018-04-29 21:11
        
        clarification regarding user Power2Stage guides mittyri 2018-04-30 13:41
- Technicality: Weigths for the inverse normal approach d_labes 2018-04-25 14:19
  - Selection of w and w* Helmut 2018-04-26 09:51
    - Selection of w and w* d_labes 2018-04-26 20:02
    - Now what? w & w* examples d_labes 2018-05-09 13:53
      - Now what? w & w* examples Ben 2018-06-10 20:12
        
        Now what? w & w* examples Helmut 2018-06-11 13:57
        
        Now what? w & w* examples Ben 2018-06-12 19:14
        
        a bug in interim.tsd.in()? mittyri 2018-06-11 23:27
        
        a bug in interim.tsd.in()? Ben 2018-06-12 19:32
        
        Nonbinding futility ruled_labes 2018-06-13 16:59
        
        Bad weather? Helmut 2018-06-13 19:23
        
        NLYW? d_labes 2018-06-14 10:18
        
        Nonbinding futility rule Ben 2018-06-13 20:26
        
        Nonbinding futility rule d_labes 2018-06-14 10:47
        
        Nonbinding futility rule Ben 2018-06-15 17:58
        
        Binding / Nonbinding futility rule - alpha control d_labes 2018-06-16 19:42
        
        Binding / Nonbinding futility rule - alpha control Ben 2019-03-30 09:52