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Biotech / Medical : ABTI Alpha-Beta Technology
ABTI 0.200+99,900.0%Jun 17 12:34 PM EST

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To: squetch who wrote (303)7/25/1997 4:12:00 PM
From: biowa   of 572
 
squetch,

First, everyone remember this is merely hypothetical. There is no indication whatsoever of the overall response rate, at least that I've heard of.

If the overall infection rate was higher than has historically been seen in untreated population, this makes it more likely that the drug had no effect. The overall rate is roughly the average of the drug group rate and the control group rate, so unless the control group did MUCH worse than historical rates (which the FDA also would not like) an overall rate at or above historic rates indicates the drug group rate was near or above the historic rates.

If the overall infection rate is VERY MUCH lower than historical rates, then we have to worry about the dread placebo effect. Especially with trials involving hospital care, you have to worry that just the fact that there is an infection control study ongoing will cause clinicians to be more diligent in traditional infection control; their awareness has been heightened and the placebo often does better than historical therapy b/c of this (along with any mental placebo effect within the patient). Thus if the overall rate (roughly the average of drug and placebo rates) is so low as to suggest unrealistically low infection rates in the drug group, assuming historical rates for the placebo group, then the placebo rate may be well below historical rates and "squeeze" the statistical significance out of any drug effect.

There is, of course no evidence of this with ABTI to date. I was merely conjecturing about potentially "leaky" information ahead of the unblinding. Hope this was all as clear as mud <g>.

Dr. Whipple (d/b/a biowa)
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