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NEUROLOGY 2008;70:1134-1140
© 2008 American Academy of Neurology
Conference Report

Ethics of placebo-controlled clinical trials in multiple sclerosis

A reassessment

C. H. Polman, MD, PhD, S. C. Reingold, PhD, F. Barkhof, MD, P. A. Calabresi, MD, M. Clanet, MD, J. A. Cohen, MD, G. R. Cutter, PhD, M. S. Freedman, MD, L. Kappos, MD, F. D. Lublin, MD, H. F. McFarland, MD, L. M. Metz, MD, A. E. Miller, MD, X. Montalban, MD, P. W. O'Connor, MD, H. Panitch, MD, J. R. Richert, MD, J. Petkau, PhD, S. R. Schwid, MD, M. P. Sormani, PhD, A. J. Thompson, MD, B. G. Weinshenker, MD and J. S. Wolinsky, MD

From the Department of Neurology (C.H.P., F.B.), Free University Medical Center in Amsterdam, The Netherlands; Scientific and Clinical Review Associates (S.C.R.), LLC, New York, NY; Research and Clinical Programs Department (S.C.R., J.R.R.), The National Multiple Sclerosis Society, New York, NY; Department of Neurology (P.A.C.), The Johns Hopkins Hospital, Baltimore, MD; Fédération de Neurologie (M.C.), CHU Hôpital Purpan, Toulouse, France; The Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic Foundation, OH; Department of Biostatistics (G.R.C.), University of Alabama at Birmingham; Division of Neurology (M.S.F.), The Ottawa Hospital–General Campus, Ottawa, ON, Canada; Department of Neurology (L.K.), University of Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS (F.D.L., A.E.M.), Mount Sinai School of Medicine, New York, NY; Neuroimmunology Branch (H.F.M.), National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD; MS Clinic (L.M.M.), Calgary Health Region and University of Calgary, AB, Canada; Unitat de Neuroimmunologia Clinica (X.M.), Hospital Universitari Vall d'Hebron, Barcelona, Spain; Division of Neurology (P.W.O.), St. Michael's Hospital, Toronto, ON, Canada; Department of Neurology (H.P.), University of Vermont College of Medicine, Burlington; Department of Statistics (J.P.), University of British Columbia, Vancouver, Canada; Department of Neurology (S.R.S.), University of Rochester Medical Center, NY; Unit of Biostatistics (M.P.S.), University of Genoa, Italy; Neuroimaging Research Unit (M.P.S.), Department of Neurology, Scientific Institute and University Ospedale San Raffaele, Milan, Italy; Department of Clinical Neurology (A.J.T.), The National Hospital for Neurology and Neurosurgery, London, UK; Department of Neurology (B.G.W.), Mayo Clinic College of Medicine, Rochester, MN; and Department of Neurology (J.S.W.), University of Texas Health Sciences Center, Houston.

Address correspondence and reprint requests to Dr. Chris H. Polman, Department of Neurology, Free University Medical Center in Amsterdam, PO Box 4075, 1007 MB Amsterdam, The Netherlands ch.polman{at}vumc.nl

The increasing number of established effective therapies for relapsing multiple sclerosis (MS) and emerging consensus for early treatment raise practical concerns and ethical dilemmas for placebo-controlled clinical trials in this disease. An international group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to reconsider prior recommendations regarding the ethics of placebo-controlled trials in MS. The group concluded that placebo-controlled trials can still be done ethically, with restrictions. For patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons (e.g., economics). Suggestions are provided to protect subject autonomy and improve informed consent procedures. Recommendations are tighter than previously suggested for placebo-controlled trials in "resource-restricted" environments where established therapies may not be available. Guidance is also provided on the ethics of alternative trial designs and the balance between study subject burden and risk, scientific rationale and interpretability of trial outcomes.

GLOSSARY: EET = established effective therapy; MS = multiple sclerosis; PPMS = primary progressive MS; SPMS = secondary progressive MS.

Supplemental data at www.neurology.org

Disclosure: The authors report no conflicts of interest.

Received July 19, 2007. Accepted in final form October 24, 2007.




Correspondence:

Read all Correspondence

Ethics of placebo-controlled clinical trials in multiple sclerosis: A reassessment
Richard B. Tenser
Neurology Online, 18 Jun 2008 [Full text]
Reply from the authors
Chris H Polman
Neurology Online, 18 Jun 2008 [Full text]

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