Still SF [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2016-10-06 22:13 (1406 d 00:12 ago) – Posting: # 16702
Views: 10,955

Hello VStus,

» But back to reality: isn't it more practical in case of HVD to perform pilot on development with let's say 50% power (wondering: replicated pilot to keep reasonable small population?), better understand in-vitro in-vivo relationship, optimize formulation and than run replicate scaled trial? In 2-stage we also need to wait for results from the 1st stage...

Nitpicking: you perform a 2-stage trial or a pilot trial because you do not know the variability, right? Which means the "let's say 50% power" in actuality means guessworking. Optimizing the formulation on basis of a pilot trial with inherently low power (=high uncertainty on the PE) is in scientific terms as solid as tarot cards or crystal healing.
I read on LinkedIn the other day: "The flat earth society has members all over the globe" :-D:-D:-D

OK, surely I will get in trouble for this post.

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

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