Assessment of Hazard Ratios in Oncology Clinical Trials Terminated Early for Superiority: A Systematic Review.

ABSTRACT:

Importance

Group sequential designs allow potential early trial termination at the interim analysis, before study completion. Traditional maximum likelihood estimate is commonly used to quantify the treatment effect in group sequential design trials; however, in published clinical trials, a bias-adjusted estimator has rarely been reported.

Objective

To emphasize the need for considering overestimation of treatment effect by applying 2 bias-adjusted estimators to previously published, early-terminated oncology clinical trials.

Evidence review

Trials published from 2013 to 2017 were identified by searching MEDLINE and Embase on February 23, 2018. This review was restricted to oncology clinical trials using group sequential designs with a single preplanned interim analys

SUBMITTER: Shimura M 

PROVIDER: S-EPMC7312398 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature