Peer Reviewed Article

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

Authors
  • Jenerius A. Aminawung
  • Nicholas S. Downing
  • Harlan M. Krumholz
  • Joseph S. Ross
  • Nilay Shah
Published
January 21, 2014
Publication
Journal of the American Medical Association (JAMA)
Discipline
Areas of Study
Geographic Areas
Document Control Number(s)
  • ISPS 14-003
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.

Description

Supplemental:

Link to abstract here.