Bioequivalence and Bioavailability Forum • Simulations mandatory

Simulations mandatory [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2024-01-09 10:31 (542 d 15:10 ago) – Posting: # 23824
Views: 8,521

Hi Achievwin,

❝ Thank you for your nice reply.

Welcome.

Just to be clear: Some authors (right now I’m reviewing a manuscript submitted to Stat Med…) believe (‼) that Pocock’s \(\small{\color{Blue}{\alpha_\text{adj}=0.0294}}\) (94.12% CI) is ‘universally’ valid – even for reference-scaling of HVDs. This is a gross misunderstanding and not even wrong. It was derived for superiority testing in a GSD (fixed sample size N) with one interim at – exactly – N/2 and known variances. The fact that it controlled the Type I Error in Potvin’s Method B (TSD in a 2×2×2 design) was a mere lucky punch.
In my example I needed \(\small{\color{Red}{\alpha_\text{adj}=0.0274}}\) (94.52% CI) to control the Type I Error.

—
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Helmut Schütz

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Complete thread:

Parallel Group Adaptive Designs Alex 2023-12-22 10:08 [Two-Stage / GS Designs]
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
  - Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
    - Strong Type I Error control + CI: Not yet… Helmut 2024-01-09 09:48
  - Strong Type I Error control + CI: Not yet… roman_max 2024-04-04 15:18
    - Parallel design: Only simulation-based methods so far Helmut 2024-04-04 20:16
      - Parallel design: Only simulation-based methods so far roman_max 2024-04-15 21:46
- Parallel Group Adaptive Designs Achievwin 2024-01-05 11:53
  - Simulations highly recommended Helmut 2024-01-05 12:40
    - Simulations highly recommended Achievwin 2024-01-08 16:55
      - Simulations mandatoryHelmut 2024-01-09 09:31
        
        Simulations mandatory Achievwin 2024-01-09 21:11
        
        Reviews are confidential Helmut 2024-01-09 22:10
        
        Reviews are confidential Achievwin 2024-01-19 15:11
        
        Not accepted and for a reason… Helmut 2024-04-04 20:22
        
        Quod licet Iovi mittyri 2024-04-05 20:33
        
        Non licet bovi Helmut 2024-04-05 21:50
        
        Non licet bovi mittyri 2024-04-05 22:21
        
        Quod licet bove? Helmut 2024-04-06 07:21