Stallard, Nigel and Friede, Tim. (2008) A group-sequential design for clinical trials with treatment selection. Statistics in Medicine, Vol.27 (No.29). pp. 6209-6227. ISSN 0277-6715

Full text not available from this repository.

Abstract

A group-sequential (design for clinical trials that involve treatment selection was proposed by Stallard and Todd (Statist. Med. 2003; 22:689-703). In this design, the best among a number of experimental treatments is selected oil the basis of data observed at the first of a series of interim analyses. This experimental treatment then continues together with the control treatment to be assessed in one or more further analyses. The method was extended by Kelly et al. (J. Biopharm. Statist. 2005; 15:641-658) to allow more than one experimental treatment to continue beyond the first interim analysis. This design controls the familywise type I error rate under the global Min hypothesis that is in the weak sense but may not strongly control the error rate particularly if the treatments selected are not the best-performing ones in some Cases for example when additional safety data are available the restriction that the best-performing, treatments continue may be unreasonable. This paper describes an extension of the approach of Stallard and Todd that enables construction Of a group-sequential design for comparison of several experimental treatments with a control treatment. The new, method Controls the type I error rate in the strong sense if the number of treatments included at each stage is specified in advance and is indicated by simulation studies to be conservative when the number of treatments is chosen based on the observed data in a practically relevant way. Copyright (C) 2008 John Wiley & Sons, Ltd.

Item Type:	Journal Article
Subjects:	Q Science > QA Mathematics R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Clinical trials -- Design, Experimental design, Drug development, Therapeutics -- Testing
Journal or Publication Title:	Statistics in Medicine
Publisher:	John Wiley & Sons Ltd.
ISSN:	0277-6715
Date:	20 December 2008
Volume:	Vol.27
Number:	No.29
Number of Pages:	19
Page Range:	pp. 6209-6227
Identification Number:	10.1002/sim.3436
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
URI:	http://wrap.warwick.ac.uk/id/eprint/28818

Data sourced from Thomson Reuters' Web of Knowledge

Request changes to a record

Actions (login required)

View Item