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Saturday, June 01, 2019 12:10:15 PM
You, yourself, said "Second, the alpha allocation issue is fuzzy. Is it .02 for PFS with OS being only sequential at a subsequent .05 (which is how the protocol read to me). Have they changed it, or was this never the case? Nobody knows."
And I said I don't know as well. I imagine that they have set their alpha to 0.05. I'm not losing sleep over it. It's not as big of a deal as you are making it out to be.
On the trial alpha allocation issue, it is probably something you should try to check out. PFS is the primary endpoint, OS is the secondary. In a standard primary/secondary design (and this trial looks to have that, though some posters disagree) then if PFS fails there is no alpha left for OS. So P on OS would formally mean zip.
Once again, I have no idea what you mean. You are just saying words that make it seem like you know what you talking about to the casual reader.
"if PFS fails there is no alpha left for OS. So P on OS would formally mean zip"
This statement is nonsense and clearly shows you do not know what you are talking about. "No alpha left for OS"? Alpha is not something that gets used up and is gone. PFS and OS are two separate ends point that are independently measured and analyzed. Saying that the primary endpoint is PFS, means that the study was specifically powered to attempt to meet this endpoint, but not powered for OS. If that fails, it does not necessarily mean that OS will fail too.
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