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- Title
Survival trial design and monitoring using historical controls.
- Authors
Wu, Jianrong; Xiong, Xiaoping
- Abstract
In this paper, we propose a multistage group sequential procedure to design survival trials using historical controls. The formula for the number of events required for historical control trial designs is derived. Furthermore, a transformed information time is proposed for trial monitoring. An example is given to illustrate the application of the proposed methods to survival trial designs using historical controls. Copyright © 2016 John Wiley & Sons, Ltd.
- Subjects
GROUP sequential design; LOG-rank test; CLINICAL trials; RANDOMIZED controlled trials; DRUG development
- Publication
Pharmaceutical Statistics, 2016, Vol 15, Issue 5, p405
- ISSN
1539-1604
- Publication type
Article
- DOI
10.1002/pst.1756