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  • Title: Sample size estimations for MRI-monitored trials of MS comparing new vs standard treatments.
    Author: Sormani MP, Rovaris M, Bagnato F, Molyneux P, Bruzzi P, Pozzilli C, Miller DH, Comi G, Filippi M.
    Journal: Neurology; 2001 Nov 27; 57(10):1883-5. PubMed ID: 11723280.
    Abstract:
    The authors estimated the sample sizes needed for exploratory trials of MS assessing the efficacy of new treatments in reducing the number of new enhancing lesions vs those of interferon-beta or glatiramer acetate. The sample sizes per arm ranged from 868 (effect: 20%) to 94 (effect: 50%) for patients with relapsing-remitting MS and from 2,484 (effect: 20%) to 361 (effect: 50%) for patients with secondary progressive MS. In MS, exploratory trials of new vs available therapies require large numbers of patients, even when MR end-points are used.
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