Re: Corporate Update - A vs KCentra trial
I'm not saying use 450 centers, either focus on a few tier 1 hospitals or focus on each *new* center you will be adding, they need handholding anyway. If you add 90 new centers/qtr, and already have 100-odd reps in the field and are already spending like drunken sailors trying to push A, and you're already doing P4 collection... just prioritize A vs KCentra collection, either in a few new Tier 1's or in each new center you add.
Most importantly, why would it take 440 patients if there is a 40% difference in mortality, and *86*% difference in homeostasis at 3 and 12 hrs (assuming KCentra does little)? I'm no biostat whiz, but an *86% effect* could show stat sig with a handful of patients, not hundreds.
Plus, centers are already using & gathering lab data with both A & KCentra. So now just prioritize a few new Tier 1 centers to *randomize* the next 10 patients, using free drug. There's no downside or much extra work. And, this isn't a "trial" for label expansion, data just needs to be *publication quality*. What teaching hospital doc doesn't want to be part of a definitive test & what will be a very cited & very talked about paper, requiring negligible work.