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 |
|---|---|
| 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
Funding Information:The author acknowledges anonymous reviewers and associate editor for their valuable comments that improved an earlier version of the paper. This work was supported in part by National Cancer Institute (NCI) support grant P30CA021765 and ALSAC.
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)