| Challenges to clinical trials in multiple sclerosis: outcome measures in the era of disease-modifying drugs. | |
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MedLine Citation:
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PMID: 21455068 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE OF REVIEW: This review summarizes standard and evolving outcome measures in multiple sclerosis (MS) clinical trials. RECENT FINDINGS: Progress in the development of MS treatments has led to an increasing number of clinical trials and a need for sensitive, timely, and clinically relevant outcome measures. Relapse rate and the Expanded Disability Status Scale remain the standard clinical outcome measures, but the MS Functional Composite continues to gain additional validation as a meaningful outcome measure. The uncertain relationship between MRI outcome measures and clinical disability has been a persistent challenge in MS clinical trials, but there is increasing evidence supporting a correlation between MRI changes and disability in relapsing-remitting MS patients. Additionally, new imaging techniques are being developed to further increase the sensitivity of MRI as a tool in MS clinical trials. Optical coherence tomography is another outcome measure gaining influence in clinical trials. Some of the greatest challenges remain in the subset of primary progressive MS clinical trials in which brain atrophy appears to be the most promising imaging outcome measure, but the optimal clinical measures and study durations are still uncertain. SUMMARY: Progress in MS clinical trials requires critical evaluation of existing and future outcome measures and their relationships to one another. |
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Authors:
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Megan Hyland; Richard A Rudick |
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Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Review |
Journal Detail:
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Title: Current opinion in neurology Volume: 24 ISSN: 1473-6551 ISO Abbreviation: Curr. Opin. Neurol. Publication Date: 2011 Jun |
Date Detail:
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Created Date: 2011-05-02 Completed Date: 2011-08-15 Revised Date: 2013-01-18 |
Medline Journal Info:
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Nlm Unique ID: 9319162 Medline TA: Curr Opin Neurol Country: England |
Other Details:
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Languages: eng Pagination: 255-61 Citation Subset: IM |
Affiliation:
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Department of Neurology, Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic* Humans Immunosuppressive Agents / therapeutic use* Magnetic Resonance Imaging Multiple Sclerosis / drug therapy* Treatment Outcome* |
| Grant Support | |
ID/Acronym/Agency:
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NS26321/NS/NINDS NIH HHS; NS38667/NS/NINDS NIH HHS; RR023564/RR/NCRR NIH HHS; RR091290/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Immunosuppressive Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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