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Biotech / Medical : XOMA. Bull or Bear?
XOMA 31.88+0.2%Nov 25 3:59 PM EST

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To: Cacaito who wrote (14632)9/17/2000 3:09:31 AM
From: manfredhasler  Read Replies (3) of 17367
 
Cacaito,

Based on my (preliminary and somehow speculative) calculations I believe within the whole group of screened patient the "right" patient population was available. And it is now obvious, that the investigators did not benefit from that - or the other way, they missed the opportunity to execute the study properly. I do not buy your argument of the logistic nightmare.

It is just natural, that all screened patients had to alert (because they were children) first their parents. Then they got to specialized organizations with doctors already alerted for this experimental treatment. Let me assume this doctors all knew that the drug should be given very early, that means as soon as possible. Why did the study protocol not mandate to give all screened children a bolus injection first (on a randomized basis of course). Then decide about the definitive entry to the study. Some criteria had to be defined just on a prospective basis for the exclusion of the patients. The real risk with this approach would be a premature termination of the study due to unwanted side-effects ... A second risk is, that this design could lead to an objective evaluation of the evaluation process with the participating hospitals, for good or for bad. But it would include the high risk patient group and show much earlier (with less patients) a potential benefit.

Just ruminating after the fact? Now, I am going to look for something in that line in the discussion section of the full paper. If not there I guess the Lancet editorial missed to comment on this point. It would lead at least to a rational for a proper new study design. And this is in contrast to what the hero doctors conclude: they suggest more education for the parents to alert them in case their children get symptoms of a cold ...

Regards,
Manfred
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