Potvin C or B? [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2012-06-02 18:54  – Posting: # 8656
Views: 9,083

Gossip:

One regulator (I leave it to your imagination which one of EMA’s working parties he belongs to) told me that

Our [i.e., his agency’s] statisticians don’t believe* that in Potvin’s Method C the patient’s risk is preserved at ~5%. They suggest to use only Method B because application of Pocock’s α 0.0294 is well known.

I suggested to tell them to have a closer look at the empiric alphas (the endless tables in the paper). BTW, specifically Method C (not B!) is recommended by the FDA and in the recent Canadian GL.



Cheers,
Helmut Schütz
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