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Gold/Mining/Energy : Vasogen-- VAS on TSE

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To: Pluvia who wrote (328)8/3/2005 9:32:51 PM
From: Clarksterh  Read Replies (1) of 377
 
"the mortality rate is higher than observed (18.9% at 6.5 months) in some recent HF trials..."

The fact that the event rate in placebo group was too high (and I agree that it was - see Yahoo posts long before today) is different than saying that they weren't stat sig.

Which is why I pointed out the number of pt's in this trial were too small to produce statistical relevance for mortality. A point anyone who conducts research understands clearly.

The p value for a trial already takes into account the size of the trial. By definition. So this is not true. What might be true is that they didn't have enough centers and so center bias crept in. E.g. Only two centers, both of whom provide poor SoC or enrollment bias. But not repeatable in a larger trial with more centers. (I know, I am being a little pedantic here since normally the two (small patient trial population and small number of centers) go together - but not always. In fact the FDA guidelines do not specify trial size, only that it be multicenter.)

Clark
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