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RegisterThai FDA [Design Issues]
Dear all,
Let me continue on this issue.
I found a guideline, US FDA, Statistical Approaches to Establishing Bioequivalence, Section VII.A.
They stated
If a crossover study is carried out in two or more groups of subjects (eg, if for logistical reasons only a limited number of subjects can be studied at one time), the statistical model should be modified to reflect the multigroup nature of the study. In particular, the model should reflect the fact that the periods for the first group are different from the periods for the second group. This applies to all of the approaches (average, population, and individual BE) described in this guidance.
If the study is carried out in two or more groups and those groups are studied at different clinical sites, or at the same site but greatly separated in time (months apart, for example), questions may arise as to whether the results from the several groups should be combined in a single analysis. Such cases should be discussed with the appropriate CDER review division.
In my opinion, I agree because they did not link between the ANOVA results and data combining in a single analysis. They question for the data combining in only cases of
1. those groups are studied at different clinical sites, or
2. at the same site but greatly separated in time (months apart, for example).
Any reason to support the concept that the data should not be combined when the group effect is significant, please share.
If anyone ever found any guideline on this issue in any view, please share.
Thanks in advance.
Regards,
boonchai_l
Edit: Guidance linked. [Helmut]
Let me continue on this issue.
I found a guideline, US FDA, Statistical Approaches to Establishing Bioequivalence, Section VII.A.
They stated
If a crossover study is carried out in two or more groups of subjects (eg, if for logistical reasons only a limited number of subjects can be studied at one time), the statistical model should be modified to reflect the multigroup nature of the study. In particular, the model should reflect the fact that the periods for the first group are different from the periods for the second group. This applies to all of the approaches (average, population, and individual BE) described in this guidance.
If the study is carried out in two or more groups and those groups are studied at different clinical sites, or at the same site but greatly separated in time (months apart, for example), questions may arise as to whether the results from the several groups should be combined in a single analysis. Such cases should be discussed with the appropriate CDER review division.
In my opinion, I agree because they did not link between the ANOVA results and data combining in a single analysis. They question for the data combining in only cases of
1. those groups are studied at different clinical sites, or
2. at the same site but greatly separated in time (months apart, for example).
Any reason to support the concept that the data should not be combined when the group effect is significant, please share.
If anyone ever found any guideline on this issue in any view, please share.
Thanks in advance.
Regards,
boonchai_l
Edit: Guidance linked. [Helmut]
Complete thread:
- Several group design with unequal washout sarawut 2012-05-08 12:36 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Several group design with unequal washout Helmut 2012-05-08 13:40
- Hidden Q? d_labes 2012-05-08 15:02
- Q unveiled Helmut 2012-05-08 15:38
- Q or not Q ? Ohlbe 2012-05-09 11:15
- "." ≠ "?" Helmut 2012-05-09 12:28
- Q or not Q ? Ohlbe 2012-05-09 11:15
- Q unveiled Helmut 2012-05-08 15:38
- Several group design with unequal washout sarawut 2012-05-08 16:49
- Hidden Q? d_labes 2012-05-08 15:02
- Several group design with unequal washout sarawut 2012-06-05 06:02
- Several group design with unequal washout Helmut 2012-05-08 13:40
Ing. Helmut Schütz