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Hi Noha
I totally agree with ElMaestro. To my experience it is always a bad idea to run a pivotal study with more arms than just test and reference. This is what an assessor wants to see. Even if CPMP/QWP/EWP/1401/98 Rev. 1 recommends that "In studies with more than two treatment arms e.g. a three period study including two references, one from EU and another from USA the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question." it is not clear how to evaluate the study. Two treatments but 3 periods? How to handle this problem? So the easiest way is to stick to an ordinary two way cross-over....
I hope this helps
Kind regards
Dan
I totally agree with ElMaestro. To my experience it is always a bad idea to run a pivotal study with more arms than just test and reference. This is what an assessor wants to see. Even if CPMP/QWP/EWP/1401/98 Rev. 1 recommends that "In studies with more than two treatment arms e.g. a three period study including two references, one from EU and another from USA the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question." it is not clear how to evaluate the study. Two treatments but 3 periods? How to handle this problem? So the easiest way is to stick to an ordinary two way cross-over....
I hope this helps
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Two Tests with Same Reference Noha Abdeljawad 2012-11-27 08:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Crossover designs with more than 2 treatments d_labes 2012-11-27 09:51
- Crossover designs with more than 2 treatments Noha Abdeljawad 2012-11-29 07:43
- Sounds wrong to me ElMaestro 2012-11-27 12:10
- Sounds wrong to meDr_Dan 2012-11-27 14:32
- Sounds wrong to me Noha Abdeljawad 2012-11-29 07:52
- Two Tests with Same Reference jag009 2012-11-28 21:26
- FDA & multiplicity Helmut 2012-11-30 14:04
- FDA & multiplicity jag009 2012-11-30 15:16
- FDA & multiplicity Helmut 2012-11-30 16:12
- FDA & multiplicity jag009 2012-11-30 22:47
- FDA & multiplicity Helmut 2012-12-01 02:00
- FDA & multiplicity jag009 2012-12-03 21:53
- FDA & multiplicity Helmut 2012-12-01 02:00
- FDA & multiplicity jag009 2012-11-30 22:47
- FDA & multiplicity Helmut 2012-11-30 16:12
- Multiplicity: Mixed feelings ElMaestro 2012-11-30 15:24
- Multiplicity: Mixed feelings Helmut 2012-11-30 15:52
- Multiplicity: Mixed feelings martin 2012-12-03 09:24
- Multiplicity: Mixed feelings kumarnaidu 2013-12-12 11:03
- More infos, please Helmut 2013-12-12 15:27
- Multiplicity: Mixed feelings Helmut 2012-11-30 15:52
- FDA & multiplicity jag009 2012-11-30 15:16
- Two Tests with Same Reference Noha Abdeljawad 2012-12-03 08:29
- Two Tests with Same Reference jag009 2012-12-03 15:35
- X-way d_labes 2012-12-04 09:25
- design kvgreddy06 2013-12-19 15:32
- design kvgreddy06 2013-12-30 16:48
- design intuitivepharma 2013-12-31 06:44
- design kumarnaidu 2013-12-31 08:24
- Problematic design Helmut 2013-12-31 15:02
- Problematic design kvgreddy06 2014-01-03 14:46
- Problematic design kumarnaidu 2014-12-24 12:56
- Problematic design Helmut 2014-12-24 16:10
- Problematic design kumarnaidu 2014-12-26 05:38
- Two fully replicated designs? Helmut 2014-12-27 15:52
- Problematic design kumarnaidu 2014-12-26 05:38
- Problematic design Helmut 2014-12-24 16:10
- Problematic design Helmut 2013-12-31 15:02
- design kumarnaidu 2013-12-31 08:24
- design intuitivepharma 2013-12-31 06:44
- design kvgreddy06 2013-12-30 16:48
- design kvgreddy06 2013-12-19 15:32
- X-way d_labes 2012-12-04 09:25
- Two Tests with Same Reference jag009 2012-12-03 15:35
- FDA & multiplicity Helmut 2012-11-30 14:04
- Crossover designs with more than 2 treatments d_labes 2012-11-27 09:51
Ing. Helmut Schütz