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RegisterUnderrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]
Hi SKM,
it sounds like random flutter or a gender x treatment interaction? It could also be that the females increase variance, and this, I think, may be somewhat more likely.
Please show the data. Can you send us the STDM and ADAM datasets?
There are no directly relevant references. Generally speaking the innovator industry has been exploring lots and lots of opportunity for claiming population x treatment interactions, but it has so far been without much evidence.
Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated.
it sounds like random flutter or a gender x treatment interaction? It could also be that the females increase variance, and this, I think, may be somewhat more likely.
Please show the data. Can you send us the STDM and ADAM datasets?
❝ Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.
There are no directly relevant references. Generally speaking the innovator industry has been exploring lots and lots of opportunity for claiming population x treatment interactions, but it has so far been without much evidence.
Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 14:35 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Underrepresentation of female subjects in BE study to register Generic Ohlbe 2020-03-11 15:07
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 15:37
- Study planning 101 Helmut 2020-03-11 16:31
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 15:37
- Underrepresentation of female subjects in BE study to register GenericElMaestro 2020-03-11 15:24
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 16:15
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 09:27
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:41
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 10:23
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-16 09:13
- Not enough subjects to say Ohlbe 2020-03-15 19:28
- Not enough subjects to say ping4santosh 2020-03-16 09:03
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 10:23
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:41
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 09:27
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 16:15
- Underrepresentation of female subjects in BE study to register Generic jag009 2020-03-15 07:30
- Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:43
- Underrepresentation of female subjects in BE study to register Generic Ohlbe 2020-03-11 15:07
Ing. Helmut Schütz