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Comment & Response
May 28, 2014

Trial Evidence and Approval of Therapeutic Agents

Author Affiliations
  • 1SDG LLC, Cambridge, Massachusetts
JAMA. 2014;311(20):2128-2129. doi:10.1001/jama.2014.3401

To the Editor In a study of clinical trial evidence used by the US Food and Drug Administration (FDA) for approval of novel therapeutic agents, Mr Downing and colleagues1 stated that the “quality of clinical trial evidence used by the FDA as the basis for recent approvals of novel therapeutic agents varied widely across indications.” However, the parameters cited in their research—number of pivotal trials performed and assessed, median number of patients enrolled per indication, and number of pivotal trials with a duration of 6 months or more—speak to the quantity of evidence accepted for approval, not the quality of that evidence.

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