GAO report supports the FDA's effort to monitor noninferiority studies

08/29/2010 | Modern Healthcare (free registration)

A report by the Government Accountability Office shows that the FDA is taking a tougher stance on noninferiority clinical studies, which compare the efficacy of an experimental drug and an FDA-approved treatment. "The GAO report shows that these so-called noninferiority trials have often proved to be an inferior means of reviewing the safety and efficacy of new drugs," said Rep. Edward Markey, D-Mass.

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Modern Healthcare (free registration)