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A novel adaptive design strategy increases the efficiency of clinical trials in secondary progressive multiple sclerosis

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Chataway, J., Nicholas, R., Todd, S., Miller, D. H., Parsons, Nicholas R., Valdes-Marquez, E., Stallard, Nigel and Friede, Tim (2011) A novel adaptive design strategy increases the efficiency of clinical trials in secondary progressive multiple sclerosis. Multiple Sclerosis Journal, Vol.17 (No.1). pp. 81-88. doi:10.1177/1352458510382129

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Official URL: http://dx.doi.org/10.1177/1352458510382129

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Abstract

Background:Adaptive seamless designs (ASDs) have been proposed to test multiple candidate compounds using an interim decision point which allows potentially effective therapies to be taken into the next design stage and to be assessed using a phase III outcome.
Objective:To determine whether ASDs are feasible in secondary progressive multiple sclerosis (SPMS) and to compare them with conventional trial designs.
Methods:We develop an innovative adaptive trial design for SPMS, which builds on recent developments in statistical methodology. A literature search and individual clinical datasets were used to inform a framework to run simulations to evaluate the proposed design.
Results:ASDs are feasible in SPMS with MRI informing an interim decision point and Expanded Disability Status Scale (EDSS) as the final disability endpoint. Furthermore ASDs are more efficient than conventional designs with sample size savings of up to 40%. Sample sizes of 1000–1250 patients are sufficient to test up to four experimental treatments. Controlled recruitment is important to realize the full benefits of ASDs.
Conclusions:Although more complex in design, ASDs have the potential to be more efficient and more powerful than conventional designs.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Journal or Publication Title: Multiple Sclerosis Journal
Publisher: Sage Publications Ltd.
ISSN: 1352-4585
Official Date: January 2011
Dates:
DateEvent
January 2011Published
Volume: Vol.17
Number: No.1
Page Range: pp. 81-88
DOI: 10.1177/1352458510382129
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
Funder: NIHR Biomedical Research Centre , MS Society of Great Britain , Northern Ireland , Department of Health's NIHR Biomedical Research Centers
Grant number: 878/08 913/09 (Northern Ireland)

Data sourced from Thomson Reuters' Web of Knowledge

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