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Wednesday, May 03, 2017 5:36:04 AM
"Consistent with the trial design, Amarin continues to believe that the REDUCE-IT study is most likely to continue to completion of 100% of the target events. We surmise this because the efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high. Unlike the data analysis at the end of the study, the interim analysis and review by the DMC also includes robustness thresholds for certain secondary endpoints. There are potential statistical advantages for the study to run to its full term. "
Would love to know what the "efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high" specifically are. Obviously the statistical advantages at the end of the study would be the higher p value, but other than robustness of the certain secondary endpoints wonder what the primary endpoint efficacy targets were given to the DMC for stoppage.
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