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Section II - Clinical trial methodology

Published online by Cambridge University Press:  05 December 2011

Edited by
Jeffrey A. Cohen  and
Richard A. Rudick
Jeffrey A. Cohen
Affiliation:
Cleveland Clinic
Richard A. Rudick
Affiliation:
Cleveland Clinic
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Summary

This chapter deals with the measurement of impairment or disability for use in multiple sclerosis (MS) clinical trials from a medical model perspective, focusing on global clinical trial outcome measures. It addresses the methodological issues in measuring impairment and disability. The measures of neurological impairment and disability in MS can be grouped into four classes: biological assays, performance measures, rating scales and self-report measures. The Incapacity Status Scale and the multiple sclerosis (MS) Quality of Life Inventory are examples of such self-report measures, also called patient reported outcomes or PROs. Surrogate outcome measures have been studied in a variety of diseases and have been hoped for within the MS community. The development of the Multiple Sclerosis Functional Composite (MSFC) resulted from the analysis of a pooled data set of placebo control groups and natural history study databases.
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Chapter
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Multiple Sclerosis Therapeutics , pp. 56 - 299
Publisher: Cambridge University Press
Print publication year: 2011

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