Affiliations: Department of Neuroinflammation, Institute of
Neurology, University College London, Queen Square, London, UK
Note: [] Corresponding author: Department of Neuroinflammation, Institute
of Neurology, University College London, Queen Square, London WC1N 3BG, UK.
Tel.: +44 (0)20 7837 3611; Fax: +44 (0)20 7837 8553; E-mail:
[email protected]
Abstract: Cerebrospinal fluid (CSF) is the body fluid closest to the pathology
of multiple sclerosis (MS). For many candidate biomarkers CSF is the only fluid
that can be investigated. Several factors need to be standardized when sampling
CSF for biomarker research: time/volume of CSF collection, sample
processing/storage, and the temporal relationship of sampling to clinical or
MRI markers of disease activity. Assays used for biomarker detection must be
validated so as to optimize the power of the studies. A formal method for
establishing whether or not a particular biomarker can be used as a surrogate
end-point needs to be adopted. This process is similar to that used in clinical
trials, where the reporting of studies has to be done in a standardized way
with sufficient detail to permit a critical review of the study and to enable
others to reproduce the study design. A commitment must be made to report
negative studies so as to prevent publication bias. Pre-defined consensus
criteria need to be developed for MS-related prognostic biomarkers. Currently
no candidate biomarker is suitable as a surrogate end-point. Bulk biomarkers of
the neurodegenerative process such as glial fibrillary acidic protein (GFAP)
and neurofilaments (NF) have advantages over intermittent inflammatory
markers.
