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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. doi:10.1016/S0022-510X(09)70456-3 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 | ||||
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Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry |
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Divisions: | Faculty of Science, Engineering and Medicine > 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 | ||||
Official Date: | 2009 | ||||
Dates: |
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Volume: | Vol.285 | ||||
Number: | Suppl.1 | ||||
Page Range: | S113-S114 | ||||
DOI: | 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) |
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Version or Related Resource: | Paper presented at 19th World Congress of Neurology, Bangkok, Thailand, October 24 to 30, 2009. |
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