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RegisterMulticenter BE studies - center effects [Design Issues]
Ahoy d_labes
I am not sure I understand much of anything. I might not use a specification of centers in the final evaluation at all. It is a between-subject factor, so a phenomenon arising from center effects is not likely to affect your BE conclusion (perhaps a weird treatment by center interaction might potentially be confounding?!? perhaps test the raw center effect -low power- then exclude from model as nonsignificant).
If in a deficiency letter it is asked for I would probably treat center as fixed.
Subjects in Sequences in centers is treated the same as subjects in centers in sequences.
Best regards,
EM.
I am not sure I understand much of anything. I might not use a specification of centers in the final evaluation at all. It is a between-subject factor, so a phenomenon arising from center effects is not likely to affect your BE conclusion (perhaps a weird treatment by center interaction might potentially be confounding?!? perhaps test the raw center effect -low power- then exclude from model as nonsignificant).
If in a deficiency letter it is asked for I would probably treat center as fixed.
Subjects in Sequences in centers is treated the same as subjects in centers in sequences.
Best regards,
EM.
Complete thread:
- Multicenter BE studies - center effects d_labes 2009-12-17 12:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Multicenter BE studies - center effectsElMaestro 2009-12-17 12:47
- Multicenter BE studies - center effects Helmut 2009-12-17 13:47
- ICH E9 - page 12 ElMaestro 2009-12-17 14:18
- Deficiency centers d_labes 2009-12-17 15:28
- Deficiency centers Helmut 2009-12-17 15:52
- Deficiency potocol d_labes 2009-12-18 08:12
- Verbosity ElMaestro 2009-12-17 18:41
- Text gem d_labes 2009-12-18 08:34
- Deficiency centers Helmut 2009-12-17 15:52
- Deficiency centers d_labes 2009-12-17 15:28
Ing. Helmut Schütz