The role of MRI as a surrogate outcome measure in multiple sclerosis
- 1 September 2002
- journal article
- research article
- Published by SAGE Publications in Multiple Sclerosis Journal
- Vol. 8 (1_suppl), 40-51
- https://doi.org/10.1177/135245850200800109
Abstract
The need for more specific and more sensitive outcome measures for use in testing new therapies in multiple sclerosis (MS) is generally accepted. This need has been accentuated by the realization that the ability to conduct large placebo-controlled trials will be limited in the future. From the first use of magnetic resonance imaging (MRI) to study MS, the ability of this imaging technique to identify areas of the central nervous system damage by the disease process in MS has been impressive. Thus, the possibility that MRI could serve as a surrogate outcome measure in clinical trials in MS has been attractive. The use of MRI as a surrogate outcome measure has been examined by an international group of investigators with expertise in clinical aspects of MS, the use of MRI in MS, and in experimental therapeutics. The group agreed that MRI does not represent a validated surrogate in any clinical form of MS. It was also agreed, however, that MRI does provide a reflection of the underlying pathology in the disease, but no single MRI measurement in isolation was seen as sufficient to monitor disease. The use for multiple imaging techniques, especially new, emerging techniques that may better reflect the underlying pathology, was seen as particularly important in monitoring studies of patients with either secondary or primary progressive MS. The choice of MRI techniques used to monitor new therapies needs to be consistent with the proposed mechanisms of the new therapy and phase of the disease. It was also noted, however, that additional validation is required for nonconventional imaging techniques. Finally, the participants noted that clinical trials using MRI as a primary outcome measure may fail to fully identify the effects of the therapy on clinical measures and that the risk and cost-benefit ratio of the treatment might be unresolved. Thus, before MRI is used as a primary outcome measure, new approaches to trial design must be given careful consideration. Multiple Sclerosis (2002)8, 40-51Keywords
This publication has 74 references indexed in Scilit:
- Human Immunodeficiency Virus Type 1 RNA Level and CD4 Count as Prognostic Markers and Surrogate End Points: A Meta-AnalysisAIDS Research and Human Retroviruses, 2000
- One year follow up study of primary and transitional progressive multiple sclerosisJournal of Neurology, Neurosurgery & Psychiatry, 2000
- Lesion heterogeneity in multiple sclerosis: a study of the relations between appearances on T1 weighted images, T1 relaxation times, and metabolite concentrationsJournal of Neurology, Neurosurgery & Psychiatry, 2000
- Interferon-beta -1a in relapsing-remitting multiple sclerosis: effect on hypointense lesion volume on T1 weighted imagesJournal of Neurology, Neurosurgery & Psychiatry, 1999
- Randomised, double blind, placebo controlled study of interferon beta -1a in relapsing-remitting multiple sclerosis analysed by area under disability/time curvesJournal of Neurology, Neurosurgery & Psychiatry, 1999
- Magnetisation transfer of normal appearing white matter in primary progressive multiple sclerosisMultiple Sclerosis Journal, 1999
- Axonal Transection in the Lesions of Multiple SclerosisNew England Journal of Medicine, 1998
- Natural history of multiple sclerosisAnnals of Neurology, 1994
- Estimation of metabolite concentrations from localized in vivo proton NMR spectraMagnetic Resonance in Medicine, 1993
- Impact of Nuclear Magnetic Resonance Imaging on the Assessment of Multiple Sclerosis PatientsSeminars in Neurology, 1986