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.
Original language | English |
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Pages (from-to) | 405-411 |
Number of pages | 7 |
Journal | Pharmaceutical Statistics |
Volume | 15 |
Issue number | 5 |
DOIs | |
State | Published - Sep 1 2016 |
Bibliographical note
Publisher Copyright:Copyright © 2016 John Wiley & Sons, Ltd.
Keywords
- group sequential trial design
- historical control
- information time
- log-rank test
- sample size
- time-to-event
ASJC Scopus subject areas
- Statistics and Probability
- Pharmacology
- Pharmacology (medical)