My previous reasoning was that the data for interi
Post# of 147668
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Posted On: 12/27/2020 10:52:22 AM
Re: Goosebumps #69813
My previous reasoning was that the data for interim was between p= .05 and p=.005. The DSMC and of course the FDA would have wanted to see p= .005 for a trial halt for efficacy due to the very broad confidence interval or power. The number of patients for the full trial would have been set up so p= .05 and the 390 patients would have a suitable confidence interval.
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