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Posted On: 10/20/2020 9:45:37 PM
Post# of 145875
Quote:Thanks ctd555. Very good question.
Will the 293 interim review be more or less the same as this one? (extremely high bar for p-value in order to half for efficacy?)
If so, I'm not sure why we are so focused on that, versus just getting to full enrollment. Unless we were extremely close, which we can't know.
Expressed in a slightly different way, is the P-value that will be required at 75% enrollment -- equal to the P-value that was required at 50% enrollment?
With the DSMC not advising any changes to the protocol (with the exception of wanting to look at Mortality at Day 42), I have to assume that our results were less than P=0.05 -- but greater than the P-value incorporated into the Statistical Analysis Plan based on the power of the trial 50%.
I don't have experience in this realm, but I would hope that increasing the N= to 293 would allow for a "relaxing" of the next interim required P-value, in a direction towards P=0.05
As you point out, we don't know how close we came to the 50% magic number. In other words, did the DSMC advise against protocol changes and adding Mortality at Day 42 because they felt confident we'd get a halt at 293? Or did they adopt that approach to ensure we'd succeed at 390?
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