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Biotech / Medical : Neurex Corporation
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To: Dr. John M. de Castro who wrote (397)1/15/1998 11:12:00 PM
From: NeuroInvestment  Read Replies (1) of 449
 
I respect your concern here, and I am aware that effect size diminishes with the inclusion of dropouts as nonresponders. I do not follow DEPO closely(I specialize in the neuro area alone) so there is one element that I do not know about that situation; did DEPO carry out an interim analysis? I realize that when a study is wrapped up and this kind of dropout issue results, the company has to try to put the best face possible on the data and try to sell it. The fact that this is an interim analysis means that Neurex had a choice, a choice based on some pertinent information: they have some information regarding dropout rates (they have only disclosed the 15% rate in the low dose group, and only they know what percentage of the sample fell into that category), and they are perfectly capable of ballparking estimates of how much the treatment effect would suffer by categorizing dropouts as nonresponders. While I do not always trust what management of companies say, here their action does say something; if there was a condition of statistical vulnerability here, they could have continued accruing, at the lower dose, which has the 15% dropout rate....They did not, and unless one wants to assume poor judgement on their part (and I do not have that view of their management) one would have to see this as indicating that the evaluable vs intent to treat issue is a not a potentially derailing one. We will all know more in the next 2-4 months as more information is released. NeuroInvestment
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