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Review
. 2014:2014:262350.
doi: 10.1155/2014/262350. Epub 2014 May 4.

Outcome measures in relapsing-remitting multiple sclerosis: capturing disability and disease progression in clinical trials

Amy M Lavery  1 , Leonard H Verhey  2 , Amy T Waldman  3
Affiliations
Review

Outcome measures in relapsing-remitting multiple sclerosis: capturing disability and disease progression in clinical trials

Amy M Lavery et al. Mult Scler Int. 2014.

Abstract

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that manifests as acute relapses and progressive disability. As a primary endpoint for clinical trials in MS, disability is difficult to both characterize and measure. Furthermore, the recovery from relapses and the rate of disability vary considerably among patients. Given these challenges, investigators have developed and studied the performance of various outcome measures and surrogate endpoints in MS clinical trials. This review defines the outcome measures and surrogate endpoints used to date in MS clinical trials and presents challenges in the design of both adult and pediatric trials.

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Figures

Figure 1
Figure 1
Clinical outcome measures and surrogate endpoints in Phase 3 clinical trials.
See this image and copyright information in PMC

References

    1. Fleming TR, Powers JH. Biomarkers and surrogate endpoints in clinical trials. Statistics in Medicine. 2012;31:2973–2984. - PMC - PubMed
    1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Annals of Internal Medicine. 1996;125(7):605–613. - PubMed
    1. Kurtzke JF. Historical and clinical perspectives of the expanded disability status scale. Neuroepidemiology. 2008;31(1):1–9. - PubMed
    1. Balcer LJ. Clinical outcome measures for research in multiple sclerosis. Journal of Neuro-Ophthalmology. 2001;21(4):296–301. - PubMed
    1. Ebers GC, Heigenhauser L, Daumer M, Lederer C, Noseworthy JH. Disability as an outcome in MS clinical trials. Neurology. 2008;71(9):624–631. - PubMed

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