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Hi Balakotu,
No regulatory agencies recommends interim analysis.
You can go for Sequential design but not for interim analysis of first set of subjects and analyzing the remaining set of subjects.
FDA's Old guidance states that "A sequential design, in which the decision to study a second group of subjects is based on the results from the first group, calls for different statistical methods. Those wishing to use a sequential design should consult the appropriate CDER review division.
I will raise so many concerns if you go for interim analysis of samples.
Priya.
No regulatory agencies recommends interim analysis.
You can go for Sequential design but not for interim analysis of first set of subjects and analyzing the remaining set of subjects.
FDA's Old guidance states that "A sequential design, in which the decision to study a second group of subjects is based on the results from the first group, calls for different statistical methods. Those wishing to use a sequential design should consult the appropriate CDER review division.
I will raise so many concerns if you go for interim analysis of samples.
Priya.
Complete thread:
- Bioanalysis balakotu 2014-11-28 08:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioanalysis Mahesh M 2014-11-28 08:54
- Bioanalysis Ohlbe 2014-11-28 14:15
- Stopping for futility Helmut 2014-11-28 14:21
- Bioanalysis Ohlbe 2014-11-28 14:15
- Bioanalysispriya 2014-11-28 13:41
- Bioanalysis Mahesh M 2014-11-28 08:54
Ing. Helmut Schütz