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Biotech / Medical : Neurobiological Tech (NTII) -- Ignore unavailable to you. Want to Upgrade?

To: BRAVEHEART who wrote (653)	8/16/1999 5:55:00 PM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 1494

Statistical significance is based upon three factors; the efect size (the 30% you refer to), the variation between patients (ammount of noise or error), and the sample size. The prior Phase IIA trial had a sample size of 28 memantine and 37 placebo patients with diabetic neuropathy, and an effect size of 30%. The variation was not published. But, given that the results produced a p value of .07, the variation must have been reasonable. In the Phase IIB trial the sample sizes are 125 diabetic neuropathy patients for each of two memantine dose levels and 125 placebo controls. There is plenty of statistical power here. The patients that are being selected for the trial have more severe pain levels at the beginning than the patients in the Phase IIA trial. So, there is room for even larger effect sizes and the differences between patients should be smaller in the new trial than in the old one. So, one might expect that all three of the factors that affect statistical significance should be greatly improved in the Phase IIB trial. As a result, if things go as they did in the Phase IIA trial, then the results should be highly significant. John de C