Stallard, Nigel and Todd, S. (2011) Seamless phase II/III designs. Statistical Methods in Medical Research , Vol.20 (No.6). pp. 623-634. doi:10.1177/0962280210379035

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Abstract

In recent years, there has been a drive to save development costs and shorten time-to-market of new therapies. Research into novel trial designs to facilitate this goal has led to, amongst other approaches, the development of methodology for seamless phase II/III designs. Such designs allow treatment or dose selection at an interim analysis and comparative evaluation of efficacy with control, in the same study. Methods have gained much attention because of their potential advantages compared to conventional drug development programmes with separate trials for individual phases. In this article, we review the various approaches to seamless phase II/III designs based upon the group-sequential approach, the combination test approach and the adaptive Dunnett method. The objective of this article is to describe the approaches in a unified framework and highlight their similarities and differences to allow choice of an appropriate methodology by a trialist considering conducting such a trial.

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:	Statistical Methods in Medical Research
Publisher:	Sage Publications Ltd.
ISSN:	0962-2802
Official Date:	December 2011
Dates:	Date Event December 2011 Published
Volume:	Vol.20
Number:	No.6
Page Range:	pp. 623-634
DOI:	10.1177/0962280210379035
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access

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