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Re: vorlon1966 post# 6170

Saturday, 07/19/2014 11:03:03 PM

Saturday, July 19, 2014 11:03:03 PM

Post# of 9930
It's called a stoppage rule.
The DMC will determine the threshold for such a recommended stoppage.
Many in the industry argue that early stoppage may skew the results of a study.
But in some cases where safety is assured and efficacy is supreme then such stoppage is considered ethical in oncology cases and moving the comparator group to the investigational drug advisable.

It's in the FDA rule book.
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