Quantitative Bias Analysis for Single-Arm Trials With External Control Arms.

ABSTRACT:

Importance

Unmeasured confounding is a key concern for decision-makers when observational datasets are used to assemble external control arms (ECAs) for single-arm trials.

Objective

To investigate the utility of quantitative bias analysis (QBA) for exploring the sensitivity to unmeasured confounding of nonrandomized analyses using ECAs.

Design, setting, and participants

This study emulated 15 treatment comparisons using experimental arms from existing randomized trials in advanced non-small cell lung cancer (aNSCLC) conducted after 2011 and ECAs derived from observational data. Participants were eligible individuals diagnosed with aNSCLC between January 1, 2011, and March 1, 2020. After adjustment for measured baseline confounders, a prespecified QBA was conducted to

SUBMITTER: Gupta A 

PROVIDER: S-EPMC11947839 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature