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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