Examining evidence of time-dependent treatment effects: an illustration using regression methods.

ABSTRACT:

Background

For the design and analysis of clinical trials with time-to-event outcomes, the Cox proportional hazards model and the logrank test have been the cornerstone methods for many decades. Increasingly, the key assumption of proportionality-or time-fixed effects-that underpins these methods has been called into question. The availability of novel therapies with new mechanisms of action and clinical trials of longer duration mean that non-proportional hazards are now more frequently encountered.

Methods

We compared several regression-based methods to model time-dependent treatment effects. For illustration purposes, we used selected endpoints from a large, community-based clinical trial of low dose daily aspirin in older persons. Relative and absolute estimands were def

SUBMITTER: Jachno KM 

PROVIDER: S-EPMC9535854 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature