Survival trial design and monitoring using historical controls |
| |
| Authors: | Jianrong Wu Xiaoping Xiong |
| |
| Institution: | Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA. |
| |
| 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. |
| |
| Keywords: | group sequential trial design historical control log‐rank test information time sample size time‐to‐event |
|
|
