IPIC Message Board - Msg: 2785189

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Biotech / Medical : IPIC

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Aug 15 3:35 PM EST

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To: Pancho Villa who wrote (891)	11/21/1997 8:40:00 AM
From: NeuroInvestment	Read Replies (1) of 1359

There is some misunderstanding regarding the structure of the BEST study here. An independent safety board reviews data from the study every 1-2 months. If they find that there is a statistically significant benefit to the use of the drug established prior to the completion of patient accrual, this would mean that to continue accrual is unethical, because those patients receiving placebo would be exposed to the risk of greater mortality.Since Bextra is similar (albeit with a slightly better risk profile in terms of vasoconstriction) to SmithKline's Coreg, a similar magnitude of effect is anticipated. Coreg's trials were stopped early via the same mechanism, and Tony Butler is simply extrapolating this to the Bextra timeframe (e.g. how many patients does it take to establish statistical validation). There is no 'preliminary efficacy data', it is the Coreg experience that is the template for comparison. If we do not hear of the trial being stopped within the next 3-6 months, that would raise concerns as to Bextra's efficacy compared to Coreg. NeuroInvestment

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