0.0501 not acceptable [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2016-06-02 13:30 (2061 d 16:23 ago) – Posting: # 16379
Views: 7,270

Hi David,

welcome to the forum!

» Nice one Helmut, never heard!

From Stephen’s Statistical Issues in Drug Development, p.457.

I fully agree with your point of view.

» So it will be a matter of time until Stephen's definition will be outdated

I’m not sure if I’ll live long enough. What is the average age of members of the EMA’s Biostatistical Working Party? A member of the PKWP officially asked the BWSP whether a TIE of 0.0501 [sic] is acceptable and the answer was “No!”

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