Impact of minimum stage 2 sample size on the Type I Error [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2016-12-30 12:12  – Posting: # 16910
Views: 3,965

Hi Helmut,

I am sure you are right but I can't follow you, I mean can't readily understand what question you tried to answer.
So let me ask the forbidden question: "Can you reformulate?"

» Higher sample size ⇒ more degrees of freedom ⇒ narrower CI ⇒ higher probability to pass BE.
» In other words, the TIE will also increase and one would have to use a lower adjusted α.

This is one thing I did not get. Does that logic also work when we simulate true GMR 0.8 or 1.25 for type I error? I find it hard to convince myself.

Somehow I guess regulators just wanted to say that inclusion of a single subject in stage 2 would not be ok. They are right and that is not rocket science.

I could be wrong, but...
Best regards,

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