Bioequivalence and Bioavailability Forum • Study conduct in groups

Study conduct in groups [Design Issues]

posted by Helmut – Vienna, Austria, 2015-02-02 14:08 (4159 d 09:21 ago) – Posting: # 14351
Views: 30,020

Hi Smitha,

please search the forum before posting. We discussed this issue numerous times before.

The FDA stated in letters to applicants (nothing in any guidance!):

If all of the following criteria are met, it may not be necessary to test for group effects in the model:
the clinical study takes place at one site;

all study subjects have been recruited from the same enrollment pool;

all of the subjects have similar demographics; and

all enrolled subjects are randomly assigned to treatment groups at study outset
In this latter case, the appropriate statistical model would include only the factors Sequence, Period, Treatment and Subject(nested within sequence).

I you want to avoid trouble with a statistical model incorporating a group-term (which might turn out to be significant by chance) I would go with 40 in your case.

No idea about the EMA.

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Helmut Schütz

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Complete thread:

Study conduct in groups Smitha 2015-02-02 04:21
- Study conduct in groups ElMaestro 2015-02-02 08:21
- Study conduct in groupsHelmut 2015-02-02 13:08
  - Study conduct in groups Smitha 2015-02-04 04:30
    - Study conduct in groups Helmut 2015-02-04 12:57
      - Study conduct in groups felipeberlinski 2015-02-04 22:36
        
        Study conduct in groups ElMaestro 2015-02-04 23:58
        Significant ≠ relevant Helmut 2015-02-05 00:49
        
        Significant ≠ relevant Astea 2016-03-24 20:10
        
        Significant ≠ relevant ElMaestro 2016-03-24 23:12
        Significant ≠ relevant zizou 2016-03-25 21:41
        
        Loss of power etc. Helmut 2016-03-26 14:46
        
        Loss of power etc. Astea 2016-03-27 21:18
        Loss of power etc. zizou 2016-03-27 23:44
        
        Combined power? Helmut 2016-03-28 14:29
        Loss of power etc. Astea 2016-03-28 23:57
        
        Loss of power etc. ElMaestro 2016-03-29 00:16
        Mystery Helmut 2016-03-29 17:28
        
        Back to the Future Astea 2016-03-29 21:57
        
        Back to the Future ElMaestro 2016-03-29 23:11
        
        Using lectures != Reading them mittyri 2016-03-30 00:17
        
        Recycling Helmut 2016-03-30 00:42
        
        Recycling Astea 2016-03-30 12:23
        
        Recycling Beholder 2016-03-30 13:00