Methodology of clinical trials in multiple sclerosis.
The scope of the paper is to summarise key issues in methodology used in clinical trials on multiple sclerosis (MS) treatment and help clinicians to better understand articles reporting the results of these trials. Relapsing ratio and disability progression based on the Expanded Disability Status Scale are currently used as clinical efficacy primary outcomes, but more global measurements should be used in future such as the MS Functional Composite. For magnetic resonance imaging (MRI) outcomes, new MRI composites and indexes are already available (Z4 score, conventional MRI-derived end-points) that, together with new MRI techniques (magnetisation- transfer MRI and proton resonance spectroscopy), offer more precise neuroimaging assessments of the disease. These efficacy measurements should be presented in articles as number needed to treat, which assists the reader to calculate and compare the treatments' power and safety.
Mitsikostas
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dmitsikostas@ath.forthnet.gr
D002986:Clinical Trials as Topic / Q000379:methods*; D004185:Disability Evaluation; D006801:Humans; D008279:Magnetic Resonance Imaging; D009103:Multiple Sclerosis / Q000628:therapy*; D012720:Severity of Illness Index