Survival trial design and monitoring using historical controls. (15th June 2016)

• Record Type: Journal Article
• Authors: Wu, Jianrong; Xiong, Xiaoping
• Is Part Of: Pharmaceutical statistics. Volume 15:Number 5(2016)
• Page Start: 405
• Page End: 411
• Publication Date: 2016-06-15
• Subjects: group sequential trial design -- historical control -- log‐rank test -- information time -- sample size -- time‐to‐event; Pharmacy -- Statistical methods -- Periodicals; Pharmacy -- Statistics -- Periodicals; 615.10727
• DOI: 10.1002/pst.1756
• Languages: English
• ISSNs: 1539-1604

Abstract

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.