Survival trial design and monitoring using historical controls.
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.
Department of Biostatistics, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, 38105, TN, USA.. jianrong.wu@stjude.org.
Jianrong
J
Wu
Department of Biostatistics, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, 38105, TN, USA.
Xiaoping
X
Xiong
D004311:Double-Blind Method; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy* / Q000401:mortality*; D015233:Models, Statistical; D010396:Penicillamine / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D015996:Survival Rate / Q000639:trends
D010396:Penicillamine
group sequential trial design; historical control; information time; log-rank test; sample size; time-to-event