Saturday, August 23, 2014 10:02:28 AM
-First interim analysis at 50% total events (77 events); stopping boundary 0.0021
-Second IA at 75% total events (115 events); stopping boundary 0.0097 [almost 0.01]
-Final analysis of designated events (153 events) 0.021
And this also was O'Brien-Flemming. The trial outlined here mirrors NW's similarly except in the final alpha of 0.02, which is actually one-sided (0.05 two-sided). NW's trial was initially designed to be higher powered at 0.01 one-sided and 0.02 two sided. Those same assumptions were used and carried over in the BSSR. Which is interesting, and the point is this: the 0.0004 stopping boundary for first interim I had previously quoted seems linked to using a two-sided formula. The one in this book is one-sided. However, NW's further powering suggests that the TWO-SIDED stopping boundary for their trial is higher (less stringent) than 0.0004, and is most likely closer to 0.002. This may be a better estimate of stopping boundaries for NW's trial:
•Check variance assumptions at 80% enrollment
•Interim for efficacy at 60% and 80% of 248 PFS events
•O’Brien-Fleming rule
•Stopping boundaries: a1= 0.002; a2= 0.01
Another interesting thing is alphapuppy's analysis which showed the following:
His analysis assumed 171 enrolled by 12/'13. Probably close, imo. But in his analysis he used an "at least" parameter for placebo group, meaning if more evented than his minimal assumption then obviously PFS for tx goes up.
In summary, if tx PFS is over 7 or 8 months higher than placebo (which nearly doubles it), then the first interim stopping boundary of 0.002 would be crossed.
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