1. Assessment of futility in clinical trials
- Author
-
Qi Jiang, Steven M. Snapinn, Mon-Gy Chen, and Tony Koutsoukos
- Subjects
Statistics and Probability ,Research design ,Time Factors ,Operations research ,Endpoint Determination ,Computer science ,Myocardial Infarction ,MEDLINE ,Interim ,Humans ,Multicenter Studies as Topic ,Ethics, Medical ,Pharmacology (medical) ,Probability ,Randomized Controlled Trials as Topic ,Pharmacology ,Clinical Trials as Topic ,Stochastic Processes ,Models, Statistical ,Actuarial science ,Term (time) ,Clinical trial ,Evaluation Studies as Topic ,Research Design ,Sample size determination ,Data Interpretation, Statistical ,Sample Size ,Predictive power ,Type I and type II errors - Abstract
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.
- Published
- 2006