Underrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2020-03-11 15:24 (266 d 22:32 ago) – Posting: # 21252
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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? :-D

» 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.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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