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Exelixis, Inc. Message Board

  • joeflow77 joeflow77 Dec 11, 2012 5:14 PM Flag

    from Ernie: Early stoppage

    If a trial sponsor anticipates the possibility of early overwhelming efficacy that they would want to stop a trial for, the provision for incorporating that possibility into the trial design is to put in one or more interim analyses. That, in fact, is what was done with Comet 1. It was not done with Comet 2 for multiple reasons. First, C2 is a relative small and short trial as it is. Second, a secondary survival analysis is required which would be confounded by a crossover. Third, it would confound the bone response endpoint validation.

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