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.
journal_name
Neurologyjournal_title
Neurologyauthors
Sormani MP,Rovaris M,Bagnato F,Molyneux P,Bruzzi P,Pozzilli C,Miller DH,Comi G,Filippi Mdoi
10.1212/wnl.57.10.1883subject
Has Abstractpub_date
2001-11-27 00:00:00pages
1883-5issue
10eissn
0028-3878issn
1526-632Xjournal_volume
57pub_type
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