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Medical News and Perspectives
November 2, 2011

FDA Advisory Decision Highlights Some Problems Inherent in Pragmatic Trials

JAMA. 2011;306(17):1851-1852. doi:10.1001/jama.2011.1570

A meeting of an advisory committee to the US Food and Drug Administration (FDA) regarding a drug to minimize stroke risk for patients with atrial fibrillation illuminated the difficulties of gleaning knowledge from pragmatic trials—studies designed to determine the effectiveness of therapies in everyday practice.

In September, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 2, with 1 abstention, to recommend that the agency approve rivaroxaban, an oral antithrombin, as an alternative treatment to warfarin, a vitamin K antagonist, for patients with atrial fibrillation. The FDA generally goes along with advisory committee recommendations.