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Biotech / Medical : Theravance - THRX

THRX 9.810

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Jan 8 4:00 PM EST

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To: Biomaven who wrote (40)	8/28/2006 12:59:45 PM
From: bio_kruncher	Read Replies (2) of 74

I think Dew was think of the case where you can find noninferiority and inferiority as it is not possible to find superiority and not find noninferiority. I think that in this case no p-value adjustment was needed nor taken but the issue is with how they described test as one-sided vs. two-sided. The customary way to describe statistical tests for registration trials is to have two-sided test at 0.05. However, we are really doing one sided tests at 0.025 because we can only claim effectiveness if new treatment is better than control. So they did a one-sided test(at 0.025) and got a pvalue of 0.053. This may make a better press release than a p-value from a two sided test which would have been 0.106, but is equivalent. In these studies, noninferiority was needed to claim effectiveness. If the test of superiority in MRSA was conditional on first achieving noninferiority overall then no alpha adjustment would be needed. The superiority is really a marketing issue. They could have presented a claim on the label and therefore promoted it more easily.

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