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Posted On: 11/11/2020 5:03:55 PM
Post# of 145886
Re: Evil Rabbit #65162
“Totally onboard to fill the trial 100%, but 293 may indeed be enough.”
I’m 50/50 on what the addition of the 2nd interim analysis by the DSMC means. On one hand I see it as the DSMC picking 293 patients as a point in the trial that may show clear statistically and clinically significant data (and lead to an EUA).
On the other hand, with the DSMC asking to look at mortality at 42 days, was the 75% added to review the 42 day data and make a recommendation moving forward (change the primary endpoint to mortality at 42 days and fully enroll). We haven’t discussed the 42 day mortality request much on this board, but it could indicate that they believe 42 day mortality data looks better than 28 day mortality.
The good news is that enrollment has increased dramatically, beyond all expectations, which means its likely that the trial will fully enroll by the end of the year or sooner and if full enrollment is required, it won’t be far behind the 75% analysis.
I’m 50/50 on what the addition of the 2nd interim analysis by the DSMC means. On one hand I see it as the DSMC picking 293 patients as a point in the trial that may show clear statistically and clinically significant data (and lead to an EUA).
On the other hand, with the DSMC asking to look at mortality at 42 days, was the 75% added to review the 42 day data and make a recommendation moving forward (change the primary endpoint to mortality at 42 days and fully enroll). We haven’t discussed the 42 day mortality request much on this board, but it could indicate that they believe 42 day mortality data looks better than 28 day mortality.
The good news is that enrollment has increased dramatically, beyond all expectations, which means its likely that the trial will fully enroll by the end of the year or sooner and if full enrollment is required, it won’t be far behind the 75% analysis.
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