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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: aknahow who wrote (8614)2/3/1999 11:32:00 PM
From: Cacaito  Read Replies (1) | Respond to of 17367
 
95% confidence level is 1 in 20 that the effect is the drug and not
by chance.

This is to say <0.05 the famous (or infamous)one.

It is not power, which for mortality trials is 80%, Power is part of the equation to get the N, or how many patients on each group, according to the expected incidence of the event vs the expected improvement.

This 1 in 20 eventually means (later after approval) that one will treat 20 patients to save one, 19 will not need the drug. The chances a physician will take are 5%.

So the chances that your asking for your child of 50% are quite risky (10 times higher than standard practice).

Due to the discrepancy of perceived risk vs actual and the big tendency of physicians to overtreat (for good) due to the relatively low ability to discern timing and diagnosis.

The FDA correctly needs to separate (and integrate) the divergent need of physicians working in the real world of uncertainty where 5% risk is huge, vs the need to prove efficacy (95% confidence).

Some argue (Neuroinvestment newsletter is one) that for severe diseases, mortality, and lack of treatment a 1 in 10 proof should be enough, this is <0.10 , but the dictatorship and tyranny of the <0.05 is the scientific mantra.