Thanks, and DKMA [Power / Sample Size]

posted by ElMaestro  – Denmark, 2017-02-06 12:46 (1534 d 13:32 ago) – Posting: # 17020
Views: 21,713

Hi Hötzi,

thanks for clarification. I am sorry I did not get it. Happens often.

» Yes, sure. I guess this is what you have done in EFG?

Not quite; when I made EFG I also believed what I was told (apparently quoting from an FDA pres. somewhere, which I don't have) that it was not possible to calculate the power / sample size in the presence of a significant treatment effect.
So in my EFG implementation I used simulation.

Later I decided we don't all to be sheep and refuted FDA's statement with three lines of code. Too bad I can't find the original presentation or statement from FDA anywhere :-D.

I hope the idea in the code above is clear enough that simulations won't be necessary.

Finally, the wording from DKMA's side is certainly a bit backward or dubious, but DKMA are currently to the best of my knowledge only enforcing the requirement in relation to substitution. Proof of BE and approval does not hinge on a CI including 1.0. I heard in my local supermarket that they are fully aware they'd be smashed totally flat if they had to convince anyone in a referral that a treatment effect precludes a conclusion of BE.

Pass or fail!

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