Bioequivalence and Bioavailability Forum • Oops!

Oops! [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2011-02-07 18:17 (5249 d 00:05 ago) – Posting: # 6572
Views: 26,964

My Capt'n!

❝ I am no expert here at all.

❝ My impression was ...

Sorry, here we have to put aside the glasses :cool:

(no semi-blind :pirate:

, but open).

Quote from the paper:

[…] the goal was to identify and validate at least one particular method that could be accepted by regulatory agencies and used by sponsors without further validation. Toward that end, the committee established a number of desirable properties that we would seek for such a method. First and most prominent was that the method had to either not inflate the type I error rate or inflate it with a determined maximum inflation judged negligible. We considered an overall type I error rate of less than 5.2% for a nominal 5% test to be a negligible inflation. Other desirable properties for the work here were:

Number of stages permitted=2.
Allow stopping (with passing results) after completing either stage if criteria are met.
No requirement for blinding to treatment effect at each stage, since data would routinely be unblinded in pharmacokinetic (PK) BE studies.
Should have better properties than current practice (which, in effect, allows multiple trials, each time tested at 5%).
Should provide a unique, unambiguous result: i.e. there should only be one outcome from any given data set. This would rule out, for example, bootstrap procedures.
Does not require poolability criteria (or at least should know whether results from both stages are poolable before sample analysis, i.e. base poolability on study conduct such as subject demographics, temporal considerations, use of same protocol, use of same site, etc., rather than a statistical test of poolability).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Potvin method B subtleties d_labes 2011-01-31 14:24 [Two-Stage / GS Designs]
- 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 rule Helmut 2011-04-19 15:28