Pediatric analgesic clinical trial designs, measures, and extrapolation: Report of an FDA Scientific Workshop

Authors

Charles B. Berde, Harvard Medical School, Boston, MA
Gary A. Walco, University of Washington, Seattle, WA
Elliot J. Krane, Stanford University
K. J.S. Anand, University of TennesseeFollow
Jacob V. Aranda, State University of New York
Kenneth D. Craig, University of British Columbia, Vancouver, BC
Carlton D. Dampier, Emory University
Julia C. Finkel, George Washington UniversityFollow
Martin Grabois, Baylor College of Medicine
Celeste Johnson, McGill University, Montreal, QC, Canada
John Lantos, University of Missouri-Kansas City
Alyssa Lebel, Harvard Medical School, Boston, MA
Lynne G. Maxwell, University of Pennsylvania
Patrick McGrath, Dalhousie University, Halifax, NS, Canada
Timothy F. Oberlander, University of British Columbia, Vancouver, BC
Laura E. Schanberg, Harvard Medical School, Boston, MA
Bonnie Stevens, Harvard Medical School, Boston, MA
Anna Taddio, Children's Hospital, Boston, MA
Carl von Baeyer, Children's Hospital, Boston, MA
Myron Yaster, Children's Hospital, Boston, MA
William T. Zempsky, Children's Hospital, Boston, MA

Document Type

Journal Article

Publication Date

2-2012

Journal

Pediatrics

Volume

Volume 129, Issue 2

Inclusive Pages

354-364

Keywords

Analgesics--adverse effects--classification--therapeutic use; Chronic Pain--drug therapy; Clinical Trials as Topic--ethics--methods; Education--ethics; Research Design; United States Food and Drug Administration--ethics

APA Citation

Berde, CB, Walco, GA, Krane, EJ, Anand, KJS, Aranda, JV, Craig, KD, Dampier, CD, Finkel, JC, Grabois, M, Johnston, C, Lantos, J, Lebel, A, Maxwell, LG, McGrath, P, Oberlander, TF, Schanberg, LE, Stevens, B, Taddio, A, Von Baeyer, CL, Yaster, M, Zempsky, WT. (2012). Pediatric analgesic clinical trial designs, measures, and extrapolation: Report of an FDA Scientific Workshop. Pediatrics, 129(2), 354-364.

Peer Reviewed

1