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Capitol Health Call
October 13, 2010

Noninferiority Trials

JAMA. 2010;304(14):1546. doi:10.1001/jama.2010.1415

The Food and Drug Administration (FDA) is doing a better job of appropriately weighing the evidence from noninferiority trials when considering approval of a new drug, said the Government Accountability Office (GAO) in an August 30 report (http://www.gao.gov/new.items/d10798.pdf).

Some critics have argued that a noninferiority drug trial, which is designed to determine if a drug candidate is as effective as an established treatment for a medical condition, is difficult to design and interpret. Because of this, they say, such trials may provide pharmaceutical manufacturers an easier avenue for getting approval to market a drug that may be less safe or efficacious than one already in use. In March, the FDA issued guidance for industry, explaining what the agency would consider proper noninferiority trials for drug approval.

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