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Vertex Pharmaceuticals Incorporated Message Board

  • agz2 agz2 Nov 15, 2005 12:58 PM Flag

    tests on each trial phase!

    Reading this board it has occurred to me that many of these emphatic statements come from people that dont even know what the phase of clinical trials typically address. Stymie for instance thinks for some unkown reason that there would no be a phase 1 if there was any "hint" of toxicity. You are absolutely wrong. Most Phase 1 trials are conducted on drugs that can be very toxic at a given dose.
    In any event, just so you know for the future, Phase 1 trial is usually a test of toxicity in response to variable dosing and a gander at efficacy. Here the FDA wants to see that a drug can be well tolerated, yes even if its a little toxic depending on the indication.

    Phase Ia,b usually focuses more on efficacy of a tolerated dose. As does Phase II which usually expands the number of subjects and really finds out about the efficacy of a drug in a larger study. This has not been done for VRTX yet mind you. Many a well tolerated promising drug in Phase I that failed efficacy standards in phase II.

    Phase III trial typically expands on tox and efficacy on a large scale and is aimed to determine best dosages, application intervals, and over details for drug administration. probably in 2008 for VRTX, if the Phase II is not a bust.

    So please stymie look into some of this stuff before you rant this way and that.

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