Thursday, July 06, 2017 12:30:30 PM
I don't know and I guess this entire argument comes down to what their definition of ROBUST is. If its .001 for key SEs, then 99.9% this will continue. But then if you define ROBUST by a P value (.001), isn't that encroaching into STATISTICAL SIGNIFICANCE?
I don't know either and I view this as more a discussion than an argument (as I am sure you do too).
The DSMB will know Robust when they see it. If they see it.
Also remember, wrt not tying their hands with specific numbers, the discussion about the possibility that V makes a MI more "survivable". That would be a good thing. But the stats would suggest more MI's in the V arm (which, under this theory, would be offset by more deaths in the placebo arm).
The DSMB must have the leeway to interpret favorable findings such as that.
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