Literature DB >> 27307025

Survival trial design and monitoring using historical controls.

Jianrong Wu1, Xiaoping Xiong2.   

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. Copyright © 2016 John Wiley & Sons, Ltd.

Entities:  

Keywords:  group sequential trial design; historical control; information time; log-rank test; sample size; time-to-event

Mesh：

Substances：

Year:  2016        PMID： 27307025      PMCID： PMC5468795          DOI： 10.1002/pst.1756

Source DB:  PubMed          Journal:  Pharm Stat        ISSN： 1539-1604            Impact factor:   1.894


  24 in total

1.  Group sequential designs for phase II trials with historical controls.

Authors:  M N Chang; J J Shuster; J L Kepner
Journal:  Control Clin Trials       Date:  1999-08

2.  Adjusted Kaplan-Meier estimator and log-rank test with inverse probability of treatment weighting for survival data.

Authors:  Jun Xie; Chaofeng Liu
Journal:  Stat Med       Date:  2005-10-30       Impact factor: 2.373

3.  The use of historical controls and concurrent controls to assess the effects of sulphonamides, 1936-1945.

Authors:  Irvine Loudon
Journal:  J R Soc Med       Date:  2008-03       Impact factor: 5.344

4.  Sequential monitoring of clinical trials: the role of information and Brownian motion.

Authors:  K K Lan; D M Zucker
Journal:  Stat Med       Date:  1993-04-30       Impact factor: 2.373

5.  Design of controlled clinical trials: use of historical controls.

Authors:  E A Gehan
Journal:  Cancer Treat Rep       Date:  1982-05

6.  Historical controls, data banks, and randomized trials in clinical research: a review.

Authors:  T R Fleming
Journal:  Cancer Treat Rep       Date:  1982-05

7.  Sample size considerations for non-randomized comparative studies.

Authors:  R W Makuch; R M Simon
Journal:  J Chronic Dis       Date:  1980

8.  Cancer clinical trials. A rational basis for use of historical controls.

Authors:  E A Gehan; E J Freireich
Journal:  Semin Oncol       Date:  1981-12       Impact factor: 4.929

9.  Implementation of group sequential logrank tests in a maximum duration trial.

Authors:  K K Lan; J M Lachin
Journal:  Biometrics       Date:  1990-09       Impact factor: 2.571

10.  Mild therapeutic hypothermia shortens intensive care unit stay of survivors after out-of-hospital cardiac arrest compared to historical controls.

Authors:  Christian Storm; Ingo Steffen; Joerg C Schefold; Anne Krueger; Michael Oppert; Achim Jörres; Dietrich Hasper
Journal:  Crit Care       Date:  2008-06-14       Impact factor: 9.097
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  2 in total

Review 1.  Trial Design Challenges and Approaches for Precision Oncology in Rare Tumors: Experiences of the Children's Oncology Group.

Authors:  Lindsay A Renfro; Lingyun Ji; Jin Piao; Arzu Onar-Thomas; John A Kairalla; Todd A Alonzo
Journal:  JCO Precis Oncol       Date:  2019-10-24

2.  Group sequential design for historical control trials using error spending functions.

Authors:  Jianrong Wu; Yimei Li
Journal:  J Biopharm Stat       Date:  2019-11-12       Impact factor: 1.051
  2 in total

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