Downing, Nicholas S., Jenerius A. Aminawung, Nilay Shah, Harlan M. Krumholz, and Joseph S. Ross. (2014). Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 311(4) doi: 10.1001/jama.2013.282034
The quality of clinical trial evidence used by the FDA as the basis for recent approvals of novel therapeutic agents varied widely across indications. This variation has important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents.
Link to abstract here.
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