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.
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A US Food and Drug Administration advisory committee’s deliberations over the ROCKET AF trial regarding rivaroxaban highlighted the difficulties of conducting pragmatic trials.
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