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vorlon1966

07/19/14 11:03 PM

#6171 RE: vorlon1966 #6170

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.