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Re: DonShimoda post# 2992

Friday, 10/29/2010 9:16:58 AM

Friday, October 29, 2010 9:16:58 AM

Post# of 80490
Re: "Despite your continued insistence that it's a 50/50 gamble"

First, BTH's argument that the trial was not stopped at the last interim implies "it is on the edge" is completely bogus.

Very few P3 trials are stopped for either futility or the P value meeting some predefined threahold like .001 . Just because a trial is stat sig at an interim does not get it stopped. The trial can only allocate a portion of the alpha to each peek, and typically it is very small to preserve the bulk of the alpha spend for the final.

On the other hand, reading the blinded event timing is a suckers game. Unknown enrollment curves, population difference between trial and historical comparators, better supportive care and just plain random luck all play a factor in clouding the numbers.

So in truth we know little now that we did not know months ago. Whatever that may mean.


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