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An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

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Stallard, Nigel. (2011) An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information. Trials, Vol.12 (Suppl.1). A2. ISSN 1745-6215

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Official URL: http://dx.doi.org/10.1186/1745-6215-12-S1-A2

Abstract

Adaptive seamless phase II/III designs enable a clinical trial to be conducted in stages with the most promising of a number of experimental treatments selected on the basis of data observed in the first stage to continue along with the control treatment to the second and any subsequent stages.

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
Library of Congress Subject Headings (LCSH): Clinical trials -- Design
Journal or Publication Title: Trials
Publisher: Bio Med Central
ISSN: 1745-6215
Date: 13 December 2011
Volume: Vol.12
Number: Suppl.1
Page Range: A2
Identification Number: 10.1186/1745-6215-12-S1-A2
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Description: Oral presentation at Clinical Trials Methodology Conference 2011, Bristol, UK. 4-5 October 2011
References: 1. Stallard N: A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information. Statistics in Medicine 2010, 29:959-971. 2. Galbraith S, Marschner IC: Interim analysis of continuous long-term endpoints in clinical trials with longitudinal outcomes. Statistics in Medicine 2003, 22:1787-1805. 3. Jennison C, Turnbull BW: Group-sequential analysis incorporating covariate information. Journal of the American Statistical Association 1997, 92:1330-1341. 4. Stallard N, Todd S: Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine 2003, 22:689-703. 5. Engel B, Walstra P: Increasing precision or reducing expense in regression experiments by using information from a concomitant variable. Biometrics 1991, 47:13-20.
URI: http://wrap.warwick.ac.uk/id/eprint/42346

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