Based on the revised timing guidance from management, I'm expecting OS of 24 months in the control arm and 30 months in the custirsen arm. Anyone else coming to similar, or maybe more importantly contradictory, conclusions?
The accrual period is 27 months (Sept 10 to Nov 12), so average was 37 patients/month. From there I assume lower patients accrued at the start of the trial while they get the 140 sites up and running. I tried to be conservative with the accrual assumptions at the start of the trial as these patients have the greatest impact on timing of events. Basically, I'm trying to avoid a false positive.
I have the trial starting with 5 patients in month 1, increasing by 5 patients per month until month 8 (April 2011 - 40 patients). From there I accrue by 40 patients per month until June 2012 where I have it up to 50 patients for the remaining 6 months of the accrual period.
Obviously, 100% assumption here, but seems reasonable enough. Thoughts?