Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

Author(s):

Nicholas S. Downing, Jenerius A. Aminawung, Nilay Shah, Harlan M. Krumholz, and Joseph S. Ross

ISPS ID:

ISPS14-003

Full citation:

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

Abstract:

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.

Supplemental information:

Link to abstract here.

Location:

United States

Publication date:

2014

Publication type:

Peer Reviewed Article

Publication name:

Journal of the American Medical Association (JAMA)

Discipline:

Medicine