Premium
Assessment of futility in clinical trials
Author(s) -
Snapinn Steven,
Chen MonGy,
Jiang Qi,
Koutsoukos Tony
Publication year - 2006
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.216
Subject(s) - interim , clinical trial , type i and type ii errors , statistical power , interim analysis , early stopping , contrast (vision) , computer science , term (time) , risk analysis (engineering) , actuarial science , medical physics , intensive care medicine , econometrics , medicine , statistics , artificial intelligence , mathematics , economics , law , political science , physics , quantum mechanics , artificial neural network
The term ‘futility’ is used to refer to the inability of a clinical trial to achieve its objectives. In particular, stopping a clinical trial when the interim results suggest that it is unlikely to achieve statistical significance can save resources that could be used on more promising research. There are various approaches that have been proposed to assess futility, including stochastic curtailment, predictive power, predictive probability, and group sequential methods. In this paper, we describe and contrast these approaches, and discuss several issues associated with futility analyses, such as ethical considerations, whether or not type I error can or should be reclaimed, one‐sided vs two‐sided futility rules, and the impact of futility analyses on power. Copyright © 2006 John Wiley & Sons, Ltd.