Group-sequential methods for adaptive seamless phase II/III clinical trials
Stallard, Nigel. (2011) Group-sequential methods for adaptive seamless phase II/III clinical trials. Journal of Biopharmaceutical Statistics, Vol.21 (No.4). pp. 787-801. ISSN 1054-3406Full text not available from this repository.
Official URL: http://dx.doi.org/10.1080/10543406.2011.551335
The last 10 years have seen considerable interest in clinical trial designs that allow the seamless combination of Phases II and III in a single clinical trial. Such designs bring together the selection of the most promising of a number of treatments, as usually performed in a Phase II clinical trial, with the rigorous analysis and control of type I error rates required for a Phase III clinical trial. Statistically, the challenge is that of allowing for multiple comparisons arising both from repeated analyses of the accumulating data and from selection of a treatment on the basis of data that will be included in the final analysis. This challenge can be met in a number of different ways. This paper reviews methods based on the group-sequential methodology for monitoring of sequential clinical trials. The main focus of the paper will be a description of the methodology, including the setting in which short-term data are used for decision making at an early interim analysis.
|Item Type:||Journal Article|
|Subjects:||Q Science > QA Mathematics
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, Clinical trials -- Statistical methods, Therapeutics -- Testing|
|Journal or Publication Title:||Journal of Biopharmaceutical Statistics|
|Publisher:||Taylor & Francis Inc.|
|Page Range:||pp. 787-801|
|Access rights to Published version:||Restricted or Subscription Access|
Special Issue: Dealing with multiplicity in drug development: current state and new directions
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