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Saturday, December 10, 2016 10:51:07 PM
A DSMC may occasionally recommend to the sponsor that a study be stopped before the planned enrollment is complete, either because of a safety problem or because patients are doing so well on the new treatment that it would be unethical not to provide all patients with the study drug as soon as possible. http://www.medscape.com/viewarticle/409917_2
I wonder where they draw the line? Multiple trials have shown Avastin 12-month survival to be around 28%. If VB-111 overall survival is 50% or higher after 12 months (and 70% of the Avastin only side have passed away - unfortunately) then would it be unethical if the trial is not stopped?
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