Tuesday, February 26, 2008 9:17:06 PM
The power is based upon an assumed advantage, but for the same drug and same trial, the true power (not of achieving the target advantage, but of achieving statistical significance) is always higher, bank on it. Therefore figure maybe 0.95*0.95 = 0.90 approx.
<Safety. This seams fairly clear. I will give it a .9>
It's barely life-threatening ? I would figure 0.75.
<The ex US arm is screwed up. .9 >
I think 0.99 because this only happens in cancer trials, and it's due to doctors ignoring protocols to help certain patients. Well why I dont know, but does anyone have evidence of a foreign screw-up* in something non-life-threatening ?
* = I just remember I think it was the Croatians who screwed up a PTIE pain drug trial or something ? And this was down to a language issue ? Well times have improved, and we can even speak Bulgarian now.
"....on the biotech battle-field, you need some élan...."
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