Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints.

ABSTRACT: We discuss group-sequential designs in superiority clinical trials with multiple co-primary endpoints, that is, when trials are designed to evaluate if the test intervention is superior to the control on all primary endpoints. We consider several decision-making frameworks for evaluating efficacy or futility, based on boundaries using group-sequential methodology. We incorporate the correlations among the endpoints into the calculations for futility boundaries and sample sizes as a function of other design parameters, including mean differences, the number of analyses, and efficacy boundaries. We investigate the operating characteristics of the proposed decision-making frameworks in terms of efficacy/futility boundaries, power, the Type I error rate, and sample sizes, while varying the num

SUBMITTER: Asakura K 

PROVIDER: S-EPMC6222168 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature