Bioequivalence and Bioavailability Forum • T1E after 1st stage in Power2Stage

T1E after 1st stage in Power2Stage [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2022-06-25 00:55 (162 d 14:15 ago) – Posting: # 23085
Views: 966

Hi mittyri,

❝ yep, I should reformulate: T1E for the adaptive study finished after 1st stage due to BE goal reached (or some other reason to stop)

See my answer above. It does not change regardless of whether you stopped after stage 1, regardless of whether alpha 1 and alpha 2 are the same or different.

A relevant perspective: Imagine you do a normal trial with a 90% CI of 88.88%-99.99%. What is the type I error? The answer is 5%.
That answer -the 5% percent- does not in any way depend on the figures. Same for the two-stage approach. The type 1 error does not change with your data, it doesn't matter if you stop at stage 1 or not.

—
Pass or fail!
ElMaestro

Complete thread:

T1E after 1st stage in Power2Stage mittyri 2022-06-24 13:43 [Two-Stage / GS Designs]
- T1E after 1st stage in TSDs Helmut 2022-06-24 14:33
  - T1E after 1st stage in TSDs mittyri 2022-06-24 21:12
    - T1E after 1st stage in TSDs Helmut 2022-06-25 14:07
      - Potvin C consequences mittyri 2022-06-25 23:29
        
        Potvin C consequences ElMaestro 2022-06-26 09:11
        
        Potvin C consequences mittyri 2022-06-27 13:45
        
        Potvin C consequences Helmut 2022-06-27 14:49
        
        from Potvin C to Inverse Normal mittyri 2022-06-27 17:13
        
        From Potvin C to Inverse Normal: history (and outlook?) Helmut 2022-06-27 18:54
        
        Potvin C consequences ElMaestro 2022-06-27 17:13
        
        true CV ≠ observed CV mittyri 2022-06-27 17:22
- T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 18:25
  - T1E after 1st stage in Power2Stage mittyri 2022-06-24 21:05
    - T1E after 1st stage in Power2StageElMaestro 2022-06-24 22:55