Well roared, lion [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2012-06-22 10:45 (4748 d 20:07 ago) – Posting: # 8824
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Dear Helmut!

❝ If you are including a fixed sample size in your method you are leaving the validated range covered by the papers. Intuitively I would say you are only jeopardizing power (higher producer’s risk) – but actually I don’t know whether the patient’s risk is unaffected.


Full ACK!
From some sparse own simulations I did (Potvin B, Nmax=120) in the past I can add:
Patient's risk found below 5%, power fairly above 80% if first stage N is not too small and CV<30%. For CV>30% (30, 35 and 40% simulated) a remarkable decrease in power was seen.
But these simulations didn't cover the full range of CV and n(stage1) to assure that patient's risk is bound to ≤0.05 under all circumstances.

Regards,

Detlew

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