Clinical trials in multiple sclerosis: milestones
- PMID: 30034537
- PMCID: PMC6048605
- DOI: 10.1177/1756286418785499
Clinical trials in multiple sclerosis: milestones
Abstract
The achievements in multiple sclerosis (MS) therapeutics are founded on the outcomes of clinical trials that demonstrate quantifiable results in treating a disease with an unpredictable course. Much has changed since the early trials in MS from the mid-20th century that compared a potential therapeutic agent with a placebo and measured outcomes based on patients' subjective reports. Advancements over the past decades have simplified diagnosis of the disease and allowed for more quantitative monitoring of its progression alongside support from paraclinical studies. Further collaborative efforts have led to pivotal meetings that steered the direction of future trials and the creation of patient databases that provided important epidemiologic information on trial subjects. These innovations and changes have improved MS clinical trials but challenge future trials to create more efficient designs lest the pace of progress necessarily slows because of the increased time to conduct such studies. As treatment options for MS broaden, clinical trials will continue to incorporate new strategies to identify novel therapies and pathways of intervention.
Keywords: clinical trials; diagnostic criteria; magnetic resonance imaging; multiple sclerosis; outcome measure.
Conflict of interest statement
Conflict of interest statement: YZ and AS declare no conflicts of interest in preparing this article. GC served on Data and Safety Monitoring Boards for AMO Pharmaceuticals, Biolinerx, Horizon Pharmaceuticals, Merck, Merck/Pfizer, Opko Biologics, Neurim, Novartis, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva pharmaceuticals, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee); served on the Consulting or Advisory Boards for Atara Biotherapeutics, Axon, Biogen, Biotherapeutics, Argenix, Brainstorm Cell Therapeutics, Charleston Labs Inc, Click Therapeutics, Genzyme, Genentech, GW Pharma, Klein-Buendel Incorporated, Medimmune, Medday, Novartis, Roche, Scifluor, Somahlution, Teva pharmaceuticals, TG Therapeutics, UT Houston. OS serves on the editorial boards of the Multiple Sclerosis Journal and Therapeutic Advances in Neurological Disorders; served on data monitoring committees for Pfizer and TG Therapeutics without monetary compensation; advised EMD Serono and Genzyme; currently receives grant support from Sanofi Genzyme; received travel support from Shire.
References
-
- Miller H, Newell DJ, Ridley A. Multiple sclerosis. Treatment of acute exacerbations with corticotrophin (A.C.T.H.). Lancet 1961; 2: 1120–1122. - PubMed
-
- Rose AS, Kuzma JW, Kurtzke JF, et al. Cooperative study in the evaluation of therapy in multiple sclerosis. ACTH vs. placebo – final report. Neurology 1970; 20: 1–59. - PubMed
-
- Rose AS, Kuzma JW, Kurtzke JF, et al. Cooperative study in the evaluation of therapy in multiple sclerosis: ACTH vs placebo in acute exacerbation. Trans Am Neurol Assoc 1969; 94: 126–133. - PubMed
-
- Kurtzke JF. A new scale for evaluating disability in multiple sclerosis. Neurology 1955; 5: 580–583. - PubMed
-
- Wulthrich R, Gigli H, Wiggli U, et al. CT scanning in demyelinating disease. In: Lanksch W, Kazner E. (eds) Cranial computerized tomography. Berlin, Heidelberg: Springer, 1976, pp.239–243.
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