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Re: rancherho post# 4581

Wednesday, 07/18/2007 8:51:07 AM

Wednesday, July 18, 2007 8:51:07 AM

Post# of 12660
This is just simple combinatorics but when you have a range from 8 to 57 with only 10 or even 22 data points and you don't know how they distribute or clump along that range, the median is rather unreliable. When you add on the aspects of a subgroup analysis with some excluded patients and a phase-2 trial where the patients are openly selected and cared for, you need to be careful with these numbers.

For example, you may recall that the phase-2 Provenge trial showed 32 weeks median TTP for the patients receiving the same dose used in the phase-3 trials D9901 and D9902a. We know now how TTP went in the phase-3's. Just in terms of trial mechanics, what might have caused the difference? Larger number of patients and blinded randomized enrollment. These parameters ensure that the good results were not solely because the patients were healthy and would have done well regardless.

Note that I am not questioning the efficacy of GVAX, esp. its use jointly with chemo or ipilimumab (which was not the subject of testing in Vital-1 anyway). I am just cautioning blind trust in the quality of these published median numbers. And a final note, you have a style of writing that exudes certainty to your readers. It is good sometimes to question whether that certainty is what you intend.

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