FDA Drug Approvals: Quality of Evidence Varies Widely

Thursday, January 23, 2014 | FDA Approval/Clearance


Although many patients and physicians assume that the safety and effectiveness of new drugs are well understood, the quality of clinical trial evidence the US Food and Drug Administration (FDA) uses for approvals varies widely, new research indicates. Nicholas S. Downing, AB, from the Yale University School of Medicine, New Haven, Connecticut, and colleagues researched the strength of clinical trial evidence that led to FDA approvals for new drugs by studying key features of pivotal efficacy trials (the clinical trials that influence FDA approval), such as trial size, design, length, and endpoints.

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