Novartis deal on the rocks, page-164

I agree it may have only just scraped past futility at the 45% enrollment (135 patients) we don't really know however we can have a reasonable guess at the numbers required for either overwhelming efficacy or futility.
I think a 10% variation off track would trigger a recommendation to stop the trial so any thing less than 32% reduction in mortality would I believe have resulted in the trial been stopped for futility.

So in the worst case at 60% enrollment we may have seen this drop by about 2% or 30% survival benefit.

Not a bad effort for a first time trial.

The DSMC suggests to stop enrollment with out making any attempt to save the trial by changing eligibility criteria , they could have. Why not ?

The DSMC could have also recommend closing the trial
and unblind the trial. Why not? They have seen enough to understand that secondary endpoints are very important.

TRIAL DESIGN HAS CHANGED ?
My understanding is that the trial was to be unblinded and read out 30 days after complete enrollment, we now are looking at 60 days. They must consider that one of the 60 day secondary endpoints should be used as a complimentary primary end point.

The DSMC has obviously concluded that the primary end point was unlikely to be met however the trial is not futile. To me this must be something huge other wise they would have closed the trial. Let it be unblinded and let the sponsor and FDA work out what to do next after all people are dieing in the US and around a 30% reduction in mortality is pretty bloody good.

Good luck all