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freethemice

02/28/12 11:03 AM

#75839 RE: Thurly #75832

Thurly,
I see your point, but the protocol still does not let the patient switch from one treatment to another. I guess the question is, how is the stopping point determined? That is, what events need to happen for the unblinding to occur? This has to be written into the protocol before the trial starts. Is it when median PFS occurs, or when ORR is determined at some time after all treatment has been delivered? Is an external data monitoring board involved? I would like the answers to these questions to be made clear.