Group sequential designs for cancer immunotherapy trial with delayed treatment effect.

ABSTRACT: Cancer immunotherapy trials are frequently characterized by delayed treatment effects such that the proportional hazards assumption is violated and the log-rank test suffers a substantial loss of statistical power. To increase the efficacy of the trial design, a variety of weighted log-rank tests have been proposed for fixed sample and group sequential trial designs. However, in such a group sequential design, it is often not recommended for futility interim monitoring due to possible delayed treatment effect which could result a high false-negative rate. To resolve this problem, we propose a group sequential design using a piecewise weighted log-rank test which provides an event-driven approach based on number of events after the delayed time. That is, the interim looks will not be conduc

SUBMITTER: Wu J 

PROVIDER: S-EPMC10403626 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature