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Pyrrhonian

12/20/14 2:37 PM

#27199 RE: Basin Street Blues #27198

No, that is absolutely unacceptable. It would immediately inform everyone that the difference between groups is great (especially at a first interim and especially for a trial with no randomized Ph II precursor). Perhaps even p < 0.001. That would introduce severe bias, and thus type I error would abound. This would confound results in the eyes of regulators and jeopardize the trial.

They will either say nothing or say the trial will continue with such wording that it is not "the DMC recommends.." However, I think the steering committee would keep these details from most of management (one member is likely on the steering committee). The steering committee will be the ones to relay to management what was decided based on instructions given to them prior to unblinding the DMC.

With all that happened last time I suspect NW will just remain quiet unless they do decide to halt.