my reading of the phase II study is that there is a difference...

my reading of the phase II study is that there is a difference in EF, ESV and EDV when you look at the highest risk group (those with ESV > 100ml), though this is a post-hoc analysis which you shouldn't do in a good phase III study. Granted there was no difference with the rest of the patients, but being able to show a difference only when you look at the highest risk patients is not uncommon in medicine.


aatisket - the point of the interim analysis is to make sure that it is ethical and worthwhile to continue the trial - ie that events are occuring with an incidence close enough to that used for the power analysis, and to make sure that there isn't a difference between the 2 groups (usually regarding the primary outcome) at this early point which would make continuing the trial unethical. Ie. the study could look like it's on track to show no difference between the 2 groups, but it still needs to be completed - so the statistician could tell MSB to continue the study, and also tell TEVA the surrogate endpoints weren't being achieved.