title: Assessment of futility in clinical trials.
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.
authors.affiliation: Amgen Inc., One Amgen Center Drive, 24-2-C, Thousand Oaks, CA 91320, USA. ssnapinn@amgen.com
authors.forename: Steven
authors.initials: S
authors.lastname: Snapinn
authors.forename: Mon-Gy
authors.initials: MG
authors.lastname: Chen
authors.forename: Qi
authors.initials: Q
authors.lastname: Jiang
authors.forename: Tony
authors.initials: T
authors.lastname: Koutsoukos
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D004992:Ethics, Medical; D005069:Evaluation Studies as Topic; D006801:Humans; D015233:Models, Statistical; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000188:drug therapy; D011336:Probability; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size; D013269:Stochastic Processes; D013997:Time Factors