Seamless phase II/III designs
Stallard, Nigel and Todd, S.. (2011) Seamless phase II/III designs. Statistical Methods in Medical Research , Vol.20 (No.6). pp. 623-634. ISSN 0962-2802Full text not available from this repository.
Official URL: http://dx.doi.org/10.1177/0962280210379035
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.|
|Page Range:||pp. 623-634|
|Access rights to Published version:||Restricted or Subscription Access|
Actions (login required)