..and if there's an imbalance between the 2 arms of the study the subgroup analysis should account for that. But, it’s something that’s really impossible to predict how the changing SOC is going to effect the results of the control arms - this is why we have to run double-blind. Probably one predictor would be if we reach the number of interim events necessary to trigger the interim analyses, and the general projections that can give us some a little bit of confidence that these aren't too different than what we have previously seen.
some interesting remarks are brought back to the future
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!