Terminology [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2017-02-18 16:27 (1341 d 01:03 ago) – Posting: # 17086
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Hi BE-proff,

» Rather risky - such methods must be present in our guides otherwise our designs will be rejected...

“Type 1” or “Type 2” was my proposal to introduce an unambiguous terminology. Get the paper at sci-hub. ;-)
On the contrary the Russian guideline (copypasted from the EMA’s) is ambigous (“For example, using 94.12% confidence intervals […] would be acceptable, but there are many acceptable alternatives and the choice of how much alpha to spend at the interim analysis is at the company's discretion”).

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