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Posted On: 10/17/2020 5:40:55 AM
Post# of 145909
The p value shows the likelihood of the results being true. The standard for likelihood is p = .05. With our trial because of its small size the predetermined halt value is more likely around p = .005. This ensures a halt for efficacy comes with a very high probability the results are correct. The downside is that the DSMC will not look at the EINDs or other evidence that would bolster claims to effectiveness. Even at p = .006 under the terms of the trial a recommendation for halt due to efficacy would not be forthcoming.
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