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Re: meirluc post# 208180

Sunday, 01/13/2019 4:48:29 AM

Sunday, January 13, 2019 4:48:29 AM

Post# of 700641

Nevertheless, this suggests that 46 months post surgery for the last patients is probably a very safe time for data lock since the attrition rate thereafter is going to be minimal. NWBO may decide to carry out the Data Lock earlier based on low attrition rates during the last several months. I am just guessing that the last reasonable time for data lock would be about 46 months post the last patient's surgery which coincide with June 2019.



Meirluc. Why stop your observations when people stop dying?
If you do that, you are failing to capture people who go on living!
OK so, median OS won't improve, but mean survival will go on improving. And OS48 and OS60 will beat earlier derived estimates but you won't be able to put any of that in your statistical analysis, because you have already unblinded. And then the longterm OS stats will become of academic interest only. (Except maybe to an HTA who might accept them.)

LP is not mistaken. There is an argument to keep this trial going and remaining blinded. But, there are several arguments to bring it to a close...

Personally, I'm not advocating one thing or the other, because I'm not in possession of as many facts as the company are.
But if I was, it would probably be a difficult judgement call to make!
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