Replies to post #227523 on Avid Bioservices Inc (CDMO)

[exwannabe]

Re: DMC and stops

My understanding is that for an efficacy stop the DMC only makes a recommendation to the sponsor, and it is still the sponsor's call.

In practice, all this is well defined in advance. For SUNRISE there is a document (we can not see) that says the DMC should look after X events to see if the p value is under Y. One would expect all parties to abide by this. They could deviate, but that can piss off the FDA.

In other trial designs it could be a little more complicated as they might see a benefit beyond what the trial was designed to look for. But in SUNRISE OS is the goal, and that is the end all.

EDIT: The idea that PPHM could want to see more data than the min to show stat sig is very reasonable. But it will have been baked into the trial stat plan.

[Protector]

MazelMan, the DMC can do TWO things.

1) In their quality as Data Monitoring instance they can ONLY recommend (STOP for futility or efficacy or recommend CONTINUE).

2) In their quality as the party the follows the trial for the FDA they can ORDER a STOP if the trial for instance is harmful to the population, etc. These occasions are RARE compared to #1. This was under dispute here on the board until North40K pointed to the part of the FDA regulation supporting that.