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Re: rancherho post# 5308

Wednesday, 01/16/2008 11:25:27 AM

Wednesday, January 16, 2008 11:25:27 AM

Post# of 12660
Thanks for the info. Given the fact, that the CEGE CEO conceded that Vital-1's enrollment pattern was like many other oncology survival trial, a "hockey stick", and that it is rare to get early statistically significant data, especially with the cumulative and delayed ramp up of immunotherapies, it seems there would be little point to having any interim look at all with such a low allocated alpha to it.

My guess is that they did it because they wanted to end the trial early if it repeated the ph ii results you were talking about earlier.

Note that for any given assumption of efficacy and desired powering of the trial, interim looks decrease the number of patients on average - but increase the maximum number of patients required should luck run against you.

PS I used the word 'epistemology' because it has a conotation of how well we can know the TRUTH given the data at hand. Talking about statistics, statistical rules, etc loses sight of the fact that there is a fundamental limitation. We can debate the assumptions, and thus the size, of the multiple looks penalty - but at heart it is indisputably true that some kind of penalty is required to avoid false positives. False knowledge.
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