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RegisterBE trial design as partial replicate and two stage [Regulatives / Guidelines]
Hi Helmut
Once I met someone with the same doubts and he told me that he have asked for a CHMP SA on the subject. As I remember from the talk, his opinion was that the agency was also not able to deal with this complex statistical analysis and therefore the advice was to consider the second stage group as a group effect and therefore only 90% CI's were calculated and not the 94.12%!
But this is not mandatory, as no public information is available!
Rgs
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Once I met someone with the same doubts and he told me that he have asked for a CHMP SA on the subject. As I remember from the talk, his opinion was that the agency was also not able to deal with this complex statistical analysis and therefore the advice was to consider the second stage group as a group effect and therefore only 90% CI's were calculated and not the 94.12%!
But this is not mandatory, as no public information is available!
Rgs
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- BE trial design as partial replicate and two stage Silva 2014-04-17 08:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE trial design as partial replicate and two stage ElMaestro 2014-04-17 09:17
- BE trial design as partial replicate and two stageSilva 2014-04-17 09:36
- EMA = PSRPH? Helmut 2014-04-17 15:33
- BE trial design as partial replicate and two stageSilva 2014-04-17 09:36
- BE trial design as partial replicate and two stage ElMaestro 2014-04-17 09:17
Ing. Helmut Schütz