Choice of futility boundaries for group sequential designs with two endpoints

• Published in: BMC medical research methodology Vol. 17; no. 1; pp. 119 - 10
• Main Authors: Schüler, Svenja, Kieser, Meinhard, Rauch, Geraldine
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.08.2017; BioMed Central; BMC
• Subjects: Algorithms; Analysis; Biometrics; Choice Behavior; Clinical trials; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Endpoint Determination - methods; Endpoint Determination - standards; Group sequential design; Humans; Hypotheses; Intersection-union test; Medical Futility; Models, Statistical; Monte Carlo Method; Pharmaceutical industry; Principles; Probability; Research Design - standards; Stopping for futility; Two endpoints; Group sequential design; Stopping for futility; Intersection-union test; Two endpoints

In clinical trials, the opportunity for an early stop during an interim analysis (either for efficacy or for futility) may relevantly save time and financial resources. This is especially important, if the planning assumptions required for power calculation are based on a low level of evidence. For...