The National Multiple Sclerosis Society (USA) Task Force on Placebo-Controlled Clinical Trials: Michel Clanet, MD, Hopital Purpan, Toulouse, France; Diane Cookfair, PhD, University of Buffalo, Buffalo, NY; Cliff Fridkis, Esq, Los Angeles, CA; Donald Goodkin, MD, University of California, San Francisco, CA; Renu Gupta, MD, Covance, Princeton, NJ; Hans-Peter Hartung, MD, Karl Franzens University, Graz, Austria; Russell Katz, MD, U.S. Food and Drug Administration, Rockville, MD; Robert Levine, MD, Yale University, New Haven, CT; Melody Lin, PhD, OPRR, National Institutes of Health, Rockville, MD; Robert Lisak, MD, Wayne State University, Detroit, MI; W. Ian McDonald, MB, ChB, Royal College of Physicians, London, UK; Henry McFarland, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD; John Noseworthy, MD, Mayo Clinic and Foundation, Rochester, MN; Hillel Panitch, MD, University of Maryland, Baltimore, MD; Chris Polman, MD, Free University Hospital, Amsterdam, Netherlands; Anthony Reder, MD, University of Chicago, IL; Peter Rudge, National Hospital, Queen Square, London, UK; William Sibley, MD, University of Arizona, Tucson, AZ; John Whitaker, MD, University of Alabama, Birmingham, AL; Jerry Wolinsky, MD, University of Texas HSC, Houston, TX.
Placebo-controlled clinical trials in multiple sclerosis: Ethical considerations
Article first published online: 26 APR 2001
Copyright © 2001 Wiley-Liss, Inc.
Annals of Neurology
Volume 49, Issue 5, pages 677–681, 1 May 2001
How to Cite
Lublin, F. D. and Reingold, S. C. (2001), Placebo-controlled clinical trials in multiple sclerosis: Ethical considerations. Ann Neurol., 49: 677–681. doi: 10.1002/ana.1025
- Issue published online: 26 APR 2001
- Article first published online: 26 APR 2001
- Manuscript Accepted: 4 DEC 2000
- Manuscript Revised: 10 NOV 2000
- Manuscript Received: 14 JUL 2000
The availability of partially effective therapies for some forms of multiple sclerosis (MS) raises practical and ethical issues for future placebo-controlled clinical trials. An international Task Force of clinicians, statisticians, ethicists and regulators was convened to discuss these issues and develop consensus. The Task Force concluded that placebo-controlled clinical trials in forms of MS for which partially effective therapies exist were ethical, so long as study subjects were fully apprised of the availability of such therapies and were encouraged to pursue them outside of a clinical trial. Patients who decline to utilize available treatments, after proper education and counseling, or those that fail all therapies can be considered to have no treatment alternatives and thus may participate in a placebo-controlled trial.