It seems these days as a matter of routine, investigators are “surprised” by lower event rates than they had banked on in their power calculations. This occurs across all domains in cardiology. At some point, that has to stop being a surprise.
Perhaps trialists should simply account for this fact, and plan to enrol more than they think th…
It seems these days as a matter of routine, investigators are “surprised” by lower event rates than they had banked on in their power calculations. This occurs across all domains in cardiology. At some point, that has to stop being a surprise.
Perhaps trialists should simply account for this fact, and plan to enrol more than they think they might need to. And if they happen to luck out and event rates are higher than expected, then the DSMB can step in if efficacy crosses stopping boundaries. Hopefully this will help us avoid clinically meaningless endpoints.
It seems these days as a matter of routine, investigators are “surprised” by lower event rates than they had banked on in their power calculations. This occurs across all domains in cardiology. At some point, that has to stop being a surprise.
Perhaps trialists should simply account for this fact, and plan to enrol more than they think they might need to. And if they happen to luck out and event rates are higher than expected, then the DSMB can step in if efficacy crosses stopping boundaries. Hopefully this will help us avoid clinically meaningless endpoints.