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Adaptive seamless trial designs in neurology : a case study in secondary progressive multiple sclerosis [Abstract]

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Chataway, J., Nicholas, R., Todd, S., Stallard, Nigel, Valdes-Marquez, E., Parsons, Nicholas R. and Friede, Tim. (2009) Adaptive seamless trial designs in neurology : a case study in secondary progressive multiple sclerosis [Abstract]. Journal of the Neurological Sciences, Vol.285 (Suppl.1). S113-S114. ISSN 0022-510X

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Official URL: http://dx.doi.org/10.1016/S0022-510X(09)70456-3

Abstract

Purpose: Adaptive seamless Phase II/III designs are attractive, and have been proposed for neurological settings such as: stroke, amyotrophic lateral sclerosis and pain control. In essence, they commence with a multi-arm stage, stopping treatments or treatment doses, for futility in an interim analysis (eg based on early biological markers), whilst taking the promising compound(s)/ dose(s) through to the final stage. Despite the advent of a raft of novel drug strategies in multiple sclerosis (MS) which reduce relapse rate, the problem of trying to slow or stop disease progression remains intractable. We explored the feasibility of implementing an adaptive seamless design (ASD) in the context of secondary progressive multiple sclerosis (SPMS).

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
Divisions: Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Multiple sclerosis, Clinical trials -- Methodology, Clinical trials -- Mathematical models, Clinical trials -- Design
Journal or Publication Title: Journal of the Neurological Sciences
Publisher: Elsevier BV
ISSN: 0022-510X
Date: 2009
Volume: Vol.285
Number: Suppl.1
Page Range: S113-S114
Identification Number: 10.1016/S0022-510X(09)70456-3
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
Description: Supplement issue (Abstracts of 19th World Congress of Neurology)
Version or Related Resource: Paper presented at 19th World Congress of Neurology, Bangkok, Thailand, October 24 to 30, 2009.
URI: http://wrap.warwick.ac.uk/id/eprint/37290

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