Choice of futility boundaries for group sequential designs with two endpoints.

ABSTRACT:

Background

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 example, when including two primary endpoints in the confirmatory analysis, the power of the trial depends on the effects of both endpoints and on their correlation. Assessing the feasibility of such a trial is therefore difficult, as the number of parameter assumptions to be correctly specified is large. For this reason, so-called 'group sequential designs' are of particular importance in this setting. Whereas the choice of adequate boundaries to stop a trial early for effica

SUBMITTER: Schuler S 

PROVIDER: S-EPMC5549398 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature