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Outcomes assessment in multiple sclerosis clinical trials: a critical analysis
JN Whitaker
Department of Neurology, University of Alabama and the Birmingham VA Medical Center, Birmingham, Alabama 35294, USA
HF McFarland
Neuroimmunology Branch, NINDS/NIH, Bethesda, Maryland 20892, USA
P Rudge
Institute of Neurology National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK
SC Reingold
Research and Medical Programs Department, National Multiple Sclerosis Society, New York, New York 10017, USA
The feasibility and precision of clinical trials for the treatment of MS must be improved Subsequent to the approval by the Food and Drug Administration of the United States of interferon beta-1b as a safe and effective, though not curative, treatment for relapsing-remitting MS, the testing of other agents in this disease has been undertaken or is anticipated. This report summarises the discussions and recommendations of an international workshop held to review critically the elements of current MS therapeutic trials and to identify the most important aspects of clinical evaluation, study design and data analysis that would allow agents for MS to be tested as accurately, rapidly and economically as possible. While acknowledging the many uncertainties about the pathophysiology and natural history of MS, the workshop participants made recommendations about the preferred components to be used in the design of trials which may be different depending on the treatment goal and agent studied. It was concluded that the formulation of a useful clinical trial design must be based on specific guidelines for clinical scales and imaging for which task forces were recommended and subsequently appointed.
Key Words: clinical scales • clinical trials • magnetic resonance imaging • surrogate markers
Multiple Sclerosis, Vol. 1, No. 1,
37-47 (1995)
DOI: 10.1177/135245859500100107
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