Sample size estimations for MRI-monitored trials of MS comparing new vs standard treatments.

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

Neurology

journal_title

Neurology

authors

Sormani MP,Rovaris M,Bagnato F,Molyneux P,Bruzzi P,Pozzilli C,Miller DH,Comi G,Filippi M

doi

10.1212/wnl.57.10.1883

subject

Has Abstract

pub_date

2001-11-27 00:00:00

pages

1883-5

issue

10

eissn

0028-3878

issn

1526-632X

journal_volume

57

pub_type

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