I'm asking a possible naive question, regarding coumadin vs. direct inhibitors, as this is outside of my field, but is really more a general question: is there a possibility of introducing a bias in this type of trial design, by randomizing drug switches. I'm thinking that, by definition, you are taking a population who is at least not doing terribly on a specific drug, (so chopping off one end of the bell curve) and possibly even doing well, and potentially exposing them to a different drug where all outcomes are in play. Is this a valid concern?
Another way to ask this: Imagine the opposite scenario, would we expect to see the same results? Is it possible that if you took the same patient population, except they were patients who happened to be on the direct inhibitors, and then randomized to switch to coumadin, that this trial would show that COUMADIN has the increased risks? Is the initial drug given a leg up, regardless of their relative profiles?
Coumadin beats DOAC, ECMO fails, When RCTs needed, Bad COVID Policy
Such a great discussion, as always! On point (European here)
I'm asking a possible naive question, regarding coumadin vs. direct inhibitors, as this is outside of my field, but is really more a general question: is there a possibility of introducing a bias in this type of trial design, by randomizing drug switches. I'm thinking that, by definition, you are taking a population who is at least not doing terribly on a specific drug, (so chopping off one end of the bell curve) and possibly even doing well, and potentially exposing them to a different drug where all outcomes are in play. Is this a valid concern?
Another way to ask this: Imagine the opposite scenario, would we expect to see the same results? Is it possible that if you took the same patient population, except they were patients who happened to be on the direct inhibitors, and then randomized to switch to coumadin, that this trial would show that COUMADIN has the increased risks? Is the initial drug given a leg up, regardless of their relative profiles?