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Re: inveterate post# 8960

Friday, 04/18/2014 1:36:26 PM

Friday, April 18, 2014 1:36:26 PM

Post# of 699723
I have. Great run down. Some time ago, gpb (screen name) put forward potential PFS rates currently being seen in the DCVax L trial based on his modeling. He put forth an optimistic scenario that depended on enrollment completing around July. They (the DMC) could be seeing 12 months PFS right now or greater, but are waiting on statistical significance (the p-value to lower). That would probably happen closer to the second interim. But as I mentioned the DMC can increase interim looks based on trends in the efficacy data. If it is much higher than their primary e p of 6 months PFS they almost certainly would. Perhaps at 70, 74, 78 events, etc., or perhaps just two more at 74 and 82 events. As soon as the p-value hits 0.05 they may recommend a halt. Increased looks only marginally affect alpha, especially if it is clear to investigators that they will reach stat sig before the second interim (then that second interim alpha spend would be included as an additional, unplanned look).
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