Pro/con clinical debate: It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility

被引:31
作者
Schoenfeld, DA [1 ]
Meade, MO
机构
[1] Harvard Univ, Sch Med, Boston, MA 02115 USA
[2] Harvard Univ, Sch Publ Hlth, Massachusetts Gen Hosp, Dept Biostat, Boston, MA 02115 USA
[3] McMaster Univ, Dept Med, Hamilton, ON, Canada
[4] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
来源
CRITICAL CARE | 2005年 / 9卷 / 01期
关键词
clinical research; futility; interim analysis; randomized controlled trials; stopping rules;
D O I
10.1186/cc3013
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
A few recent, large, well-publicized trials in critical care medicine have been stopped for futility. In the critical care setting, stopping for futility means that independent review committees have elected to stop the trial early - based on predetermined rules - since the likelihood of finding a treatment effect is low. For bedside clinicians the idea of futility in a clinical trial can be confusing. In the present article, two experts in the conduct of clinical trials debate the role of futility-stopping rules.
引用
收藏
页码:34 / 36
页数:3
相关论文
共 6 条
  • [1] [Anonymous], GROUP SEQUENTIAL MET
  • [2] Brower RG, 2004, NEW ENGL J MED, V351, P327
  • [3] DEMETS DL, 1982, BIOMETRIKA, V69, P661
  • [4] A simple algorithm for designing group sequential clinical trials
    Schoenfeld, DA
    [J]. BIOMETRICS, 2001, 57 (03) : 972 - 974
  • [5] TURNBULL BW, 1997, ENCY STAT SCI, V1, P521
  • [6] Wiedemann HP, 2002, CRIT CARE MED, V30, P1