Bioequivalence and Bioavailability Forum • Stopping criterion # futility rule

Stopping criterion # futility rule [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2011-04-19 17:28 (5178 d 02:22 ago) – Posting: # 6924
Views: 26,433

Dear ElMaestro!

❝ ❝ There’s no stopping criterion in Potvin’s method. My protocols stated clearly that there is none in the method and were approved by the BfArM and two IECs. Experiences?

❝

❝ Potvin's method B/C/D contain a stopping criterion. This is when you after stage 1 realise it's game over.

Agree. What IECs are used to (from phase III studies) is a maximum number of subjects, i.e., some kind of futility rule - which is not included in Potvin’s method. Sponsors may run out of steam realising that after stage 1 in 24 subjects they would have to go with another 96 in stage 2.

—
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Helmut Schütz

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Complete thread:

Potvin method B subtleties d_labes 2011-01-31 14:24
- Potvin method B subtleties jdetlor 2011-02-01 17:17
  - Potvin method B subtleties d_labes 2011-02-02 09:15
    - Potvin method B subtleties jdetlor 2011-02-02 16:08
      - Gould d_labes 2011-02-02 16:25
        
        Gould jdetlor 2011-02-02 17:02
- Another one ... d_labes 2011-02-07 14:32
  - Oops! Helmut 2011-02-07 15:24
    - Oops! d_labes 2011-02-07 16:29
      - Oops! Helmut 2011-02-07 16:47
        
        Oops! ElMaestro 2011-02-07 17:06
        
        Oops! Helmut 2011-02-07 17:17
        
        Oops! ElMaestro 2011-02-07 18:35
        
        Simul'ants in my pants d_labes 2011-02-08 09:07
        
        Need for speed... ElMaestro 2011-02-13 10:57
        
        Need for speed... d_labes 2011-02-15 14:06
        
        Need for speed... ElMaestro 2011-02-15 17:39
        
        Pocock alpha's d_labes 2011-02-16 09:18
        
        ElMaestro's brain ElMaestro 2011-02-16 09:32
        
        ElMaestro's brain d_labes 2011-02-16 10:05
        
        ElMaestro's brain ElMaestro 2011-02-16 12:07
        
        Numbers d_labes 2011-02-16 13:45
- Bonus counter-question ElMaestro 2011-02-07 23:44
  - Speed is the question d_labes 2011-02-08 08:36
- New paper (method D for PE 0.90) Helmut 2011-04-18 12:58
  - New paper (method D for PE 0.90) d_labes 2011-04-19 08:58
    - New paper (method D for PE 0.90) Helmut 2011-04-19 14:30
    - New paper (method D for PE 0.90) ElMaestro 2011-04-19 14:49
      - Stopping criterion # futility ruleHelmut 2011-04-19 15:28