Abstract
Existing clinical outcomes of disease activity, including relapse rates, are inherently insensitive to the underlying pathological process in MS. Moreover, it is extremely difficult to measure clinical disability in patients, which is often a retrospective assessment, and definitely not within the time frame of a clinical trial. Biomarkers , conversely are more specific for a pathologic process and if used correctly can prove invaluable in the diagnosis, stratification and monitoring of disease activity, including any subclinical activity which is not visible to the naked eye. In this chapter, we discuss the development of neurofilaments as surrogate outcomes of disability in MS. The validation and qualification are vital steps in biomarker development and to gaining acceptance in scientific community, and the pitfalls leading up to this are also discussed.
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