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Monday, August 11, 2014 11:26:26 AM
But I remain concerned, as some others about the gist of the change to the PFS end goal from 6 months to 4 months. I am not familiar with the dependence of data quality on how well it is grouped in time as you have stated. I am not familiar with a statistical consideration of grouping in that sense. For the start times to be staggered broadens when (in absolute time) progression occurs, but it does not broaden the statistics of progression. That is not the same thing. Without that, the data having been been staggered beyond expectations just elongates the trial, which can be compensated for by adding patients, enlarging the trial, but not by adding to the number of events. From my view, adding to the number of events would only be done to reduce the noise or variance, allowing a lower efficacy to be statistically meaningful. They would do this for one of two reasons. Either they think the efficacy is lower than they expected, or they are wanting to lower the target / goal to make AA easier. Not sure the latter makes sense, but within my clouded understanding, it might.
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