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Friday, 03/14/2008 2:58:31 AM

Friday, March 14, 2008 2:58:31 AM

Post# of 12660
Trial Power v. Treatment Effect
In trying to estimate the likely success of 9902B, the far more important variable to consider is the likely observed treatment effect demonstrated by the trial as designed (HR) rather than some modest increase or decrease in power. Our collective brain power would be far better utilized on that effort than on a modest change in power discussion. Does the trial as designed capture the likely strong treatment effect as evidenced in prior trials for perhaps the 20% to 30% of the treated cohort that benefit most from Provenge? Will this effect be somehow lost or diminished in 9902B as designed? Will enough of the high HR events be captured in the statistical analysis for the trial to be a success? In my view, these are the most important questions to discuss. All the rest is relatively minor.

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