(Total Views: 543)
Posted On: 10/25/2020 3:15:42 PM
Post# of 154882
“They clearly added the interim and the 42 day metric to ensure that the data is worthy of a halt.”
My opinion after initially reading the PR was that the 42 day metric was added possibly because mortality at 42 days would be lower and more statically significant at 293 patients than that of the 28 day metric. But what’s confusing is the DSMC didn’t recommend a change to the primary endpoint of 28 days, just that they wanted a data review at 293 patient to include the survival rate at 42 days. So it’s unclear exactly when they want the survival rate at 42 days besides to compare it with the 28 days survival rate at 293 patients.
“They clearly added the interim and the 42 day metric to ensure that the data is worthy of a halt.
I don’t disagree with this idea nor do I agree 100% with it. Had the DSMC’s recommendation only been to review the data at 293, I’d be more on board, but the addition of the 42 data makes it a little less likely. People are going to be upset by this question, but could the DSMC change the primary endpoint from survival at 28 days to 42 days? Or maybe survival is good/significant at 28 days but great/significant at 42 days?
My opinion after initially reading the PR was that the 42 day metric was added possibly because mortality at 42 days would be lower and more statically significant at 293 patients than that of the 28 day metric. But what’s confusing is the DSMC didn’t recommend a change to the primary endpoint of 28 days, just that they wanted a data review at 293 patient to include the survival rate at 42 days. So it’s unclear exactly when they want the survival rate at 42 days besides to compare it with the 28 days survival rate at 293 patients.
“They clearly added the interim and the 42 day metric to ensure that the data is worthy of a halt.
I don’t disagree with this idea nor do I agree 100% with it. Had the DSMC’s recommendation only been to review the data at 293, I’d be more on board, but the addition of the 42 data makes it a little less likely. People are going to be upset by this question, but could the DSMC change the primary endpoint from survival at 28 days to 42 days? Or maybe survival is good/significant at 28 days but great/significant at 42 days?
(2)
(0)
