But what is the real problem? [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2018-06-07 13:53 (903 d 12:00 ago) – Posting: # 18863
Views: 3,156

Hi Yura,

you do your study as best you can, making some assumoptions -good or bad- about GMR and CV.
At the end of the day you may show BE or not, and if you do, then it may be with a large or small margin. I guess forced BE just means the margin was large whatever that means quantitatively.
There is no real issue here. The discussions I have seen about BE consider forced BE as a hindsight phenomenon, like post-hoc power.

If you start fiddling with "forced BE" being convincingly planned before a trial then I would of course oppose it.

Remember: In principle, either the product is BE or it isn't. There just happens to be some uncertainty on the degree by which we can demonstrate it.

I could be wrong, but...

Best regards,

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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