A modified weighted log-rank test for confirmatory trials with a high proportion of treatment switching.

ABSTRACT: In confirmatory cancer clinical trials, overall survival (OS) is normally a primary endpoint in the intention-to-treat (ITT) analysis under regulatory standards. After the tumor progresses, it is common that patients allocated to the control group switch to the experimental treatment, or another drug in the same class. Such treatment switching may dilute the relative efficacy of the new drug compared to the control group, leading to lower statistical power. It would be possible to decrease the estimation bias by shortening the follow-up period but this may lead to a loss of information and power. Instead we propose a modified weighted log-rank test (mWLR) that aims at balancing these factors by down-weighting events occurring when many patients have switched treatment. As the weighting sho

SUBMITTER: Jimenez JL 

PROVIDER: S-EPMC8592474 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature