Litcius/Paper detail

Futility stopping in clinical trials, optimality and practical considerations

Yen Chang, Tianhao Song, Jane Monaco, Anastasia Ivanova

2020Journal of Biopharmaceutical Statistics15 citationsDOIOpen Access PDF

Abstract

Stopping for futility is a useful tool in a clinical trial. It is widely used in single-arm trials in oncology and in many two-arm trials. We review three stopping rules for futility. We give recommendations for the optimal timing of futility looks in two-stage trials in terms of the information fraction and the probability of stopping under the alternative hypothesis. We discuss futility stopping in trials with substantial uncertainty about the variability of the outcome and in crossover trials.

Topics & Concepts

Clinical trialEarly stoppingOptimal stoppingOutcome (game theory)MedicineCrossoverComputer scienceMedical physicsStatisticsMathematicsArtificial intelligenceInternal medicineMathematical economicsArtificial neural networkStatistical Methods in Clinical TrialsOptimal Experimental Design MethodsGenetic Associations and Epidemiology