Hello,
I wonder if anyone can be of help.
We are going to start a Phase II clinical trial to estimate
the effectiveness of a drug at alpha equal to 0.05 and Beta equal to 0.20.
The response rates are 10% at the lowest and 20% as the highest.
With Fleming two-stage design, how many patients do we need
in stage I and II? What are the numbers of response to conclude (or early
termination) the effect/ineffect in each stage?
Any help will be very much appreciated.
Many thanks
Rebecca
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