The future of multiple sclerosis therapies: redesigning multiple sclerosis clinical trials in a new therapeutic era.
Due to past success in testing and gaining regulatory approval for a variety of therapies in multiple sclerosis (MS), the conduct of future clinical trials has become increasingly problematic. An international workshop has met to discuss the issues facing the MS clinical trial community and to examine possible new strategies for the design of trials. Particular focus has been placed on trials that either avoid the use of a placebo because of ethical considerations or on designs that allow new therapies to be studied more rapidly or with fewer patients than needed in a conventional placebo-controlled trial. The discussions resulting from the workshop should provide a basis for the examination and implementation of innovative clinical trial designs in MS.
McFarland
H F
HF
Neuroimmunology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA. mcfarlandh@ninds.nih.gov
Reingold
S C
SC
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D018849:Controlled Clinical Trials as Topic / Q000941:ethics* / Q000379:methods*; D006801:Humans; D009103:Multiple Sclerosis / Q000188:drug therapy*; D018579:Patient Selection; D010919:Placebos
D000276:Adjuvants, Immunologic; D010919:Placebos