Hello everyone,

I need to do a sample size calculation. The study two arms and two endpoints. 
The two arms are two different cancer drugs and the two endpoints reflect 
efficacy (based on progression free survival) and toxicity. 

Until now, I have been trying to understand this in terms of a one-arm design, 
where the acceptable rate of efficacy might be 0.40, the unacceptable rate of 
efficacy might be 0.20, the acceptable rate of non-toxicity might be 0.85, and 
the unacceptable rate of non-toxicity might be 0.65. Then one would pick an 
alpha for the probability of accepting a poor response, an alpha for the 
probability of accepting a toxic drug, and a beta for the probability of 
rejecting a good drug.

I'm not really sure how that sort of thinking translates into a two-arm design 
though.

Ideally, I'd like the calculation to be based on a group sequential design with 
two stages, but that's certainly not necessary, and I'd be very happy to learn 
how to do things both with and without this extra element.

Any help with this would be greatly appreciated.

Thanks,

Paul

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