Addressing treatment switching in the ALTA-1L trial with g-methods: exploring the impact of model specification.

ABSTRACT:

Background

Treatment switching in randomized clinical trials introduces challenges in performing causal inference. Intention To Treat (ITT) analyses often fail to fully capture the causal effect of treatment in the presence of treatment switching. Consequently, decision makers may instead be interested in causal effects of hypothetical treatment strategies that do not allow for treatment switching. For example, the phase 3 ALTA-1L trial showed that brigatinib may have improved Overall Survival (OS) compared to crizotinib if treatment switching had not occurred. Their sensitivity analysis using Inverse Probability of Censoring Weights (IPCW), reported a Hazard Ratio (HR) of 0.50 (95% CI, 0.28-0.87), while their initial ITT analysis estimated an HR of 0.81 (0.53-1.22).

Methods

SUBMITTER: Al Tawil A 

PROVIDER: S-EPMC11660711 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature