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Outcome Measures in Clinical Trials for Multiple Sclerosis
Caspar E P van Munster1, Bernard M J Uitdehaag2
1Department of Neurology, Amsterdam Neuroscience, VUmc MS Center Amsterdam, VU University Medical Center, De Boelelaan 1117, 1081, Amsterdam, The Netherlands. c.vanmunster@vumc.nl.
CNS Drugs
|February 11, 2017
Summary
Assessing multiple sclerosis (MS) disease activity in clinical trials is challenging. This review explores traditional and novel outcome measures for evaluating MS interventions and progression, highlighting multidimensional approaches.
Area of Science:
- Neurology
- Clinical Trials
- Disease Assessment
Background:
- Multiple sclerosis (MS) disease activity assessment is complex due to its heterogeneous nature.
- Traditional clinical outcome measures (Expanded Disability Status Scale, relapse rate) and MRI metrics (lesions) have limitations in trials.
- Accurate assessment is crucial for evaluating intervention efficacy in MS clinical trials.
Purpose of the Study:
- To review the historical development and recent advancements in outcome measures for multiple sclerosis clinical trials.
- To discuss the advantages and limitations of various traditional and novel MS outcome measures.
- To highlight the potential of multidimensional measures for capturing the full spectrum of MS activity and progression.
Main Methods:
- Literature review of historical and current outcome measures used in multiple sclerosis trials.
- Discussion of clinical assessments, including the MS Functional Composite and patient-reported outcomes.
- Analysis of advanced MRI techniques and novel biomarkers for MS assessment.
Main Results:
- Traditional measures like Expanded Disability Status Scale and relapse rates remain standard but have limitations.
- Emerging measures include MS Functional Composite, patient-reported outcomes, brain atrophy, and black hole formation.
- Newer assessments like optical coherence tomography and biomarkers show promise for comprehensive MS evaluation.
Conclusions:
- Developing multidimensional outcome measures is essential for a holistic understanding of MS disease activity and progression.
- Continued refinement of existing and exploration of novel measures will improve the assessment of MS interventions.
- The concept of 'no evidence of disease activity' represents a significant advancement in MS trial endpoints.
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