Not sure if crossing the futility mark regarding efficacy is all true but the statement is a cause for concern, yes - but not sure if its the whole story...(sorry, if this was already addressed - starting dd here). From what i read (not an expert), my crude understanding is:
Cvm - our initial estimate for p3 was wrong and this will take forever... can we increase enrollment??
Fda - why you changing protocol mid trial?
1. Youre putting people in danger
2. If people are not dying.. whats the point?
3. What else have you not told us?
Idmc - just stick with original gameplan and see where it goes.
If cvm changed/amended protocol, this p3 will be futile because they would need to do another p3 for verification.
Imo.. I dont think this has much to do with the data itself but the integrity of the trial if they changed mid trial