No control arms for 2/3 of FDA's accelerated appro
Post# of 72440
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Posted On: 08/16/2017 2:05:30 PM
No control arms for 2/3 of FDA's accelerated approval drugs. So much for the bashers' claim that every clinical trial has to have a control arm.
http://www.fiercebiotech.com/biotech/fda-unde...9iaE1jWSJ9
http://www.fiercebiotech.com/biotech/fda-unde...9iaE1jWSJ9
Quote:
The study, details of which were published in the Journal of the American Medical Association, looked at the 22 drugs that won accelerated approvals in 24 indications between 2009 and 2013. About two-thirds of the trials that generated data to support these approvals lacked control arms, reflecting the FDA’s then-emerging willingness to greenlight cancer drugs on the basis of single-arm studies.
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