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Re: rancherho post# 5430

Sunday, 03/02/2008 11:32:31 PM

Sunday, March 02, 2008 11:32:31 PM

Post# of 12660
IMO, the difference in results is so dramatic between the Povenge only results and the combination results that it will be reaffirned in 9902b.

Although I do think that the Provenge+Taxotere effect is believable, esp given a number of NCI publications on Taxotere+various vaccines, there are sufficient unknowns in how Taxotere would be taken in the trial for us to be so sure of a stat sig result based solely on that possibility. For example, caseystarman reported that his friend who was randomized onto the control arm took Taxotere before Frovenge.

The conservatism of the Haybittle-Peto boundaries at the interim analyses came from applying a uniformly stringent criterion, with a nominal P-value of 0.001, at all interim analyses." If the Haybittle-Peto method is used in 9902b as well, would this reduce your assessment that the interim might be successful?

I do not have the software to compute the interim nominal alpha for Haybittle but if it's .001, the chance of meeting stat sig will be very low. For OBF, the nominal alpha is a direct function of the trigger number, the higher the trigger, the higher the alpha. So if OBF was used for 9902b, the chance of stat sig will be a function of the trigger.

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