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A better place to start. [Two-Stage / GS Designs]

posted by ElMaestro - Denmark, 2017-11-14 00:04  - Posting: # 17976
Views: 2,208

Hi d_labes,

» But that's not the problem Helmut has described, at least as I understand it. Here we initiate a stage 2 from the perspective of the AUC evaluation where it is not neccessary to initiate one.

Best I can come up with is as follows:
The only thing that determines the need for for stage 2 is the CV.
AUCt is generally having a lower CV than Cmax (for the record, I said 'generally', I did not say 'always'). Often it is about 5-20 percentage points.

So run the sims in the usual fashion, but add 5-20 points on the CV for the power and sample size estimation.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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