Use of negative control outcomes to assess the comparability of patients initiating lipid-lowering therapies

NCOs had been proposed as tools to assess unmeasured confounding in comparative drug studies, but their real-world performance had not been rigorously validated in a large lipid-lowering therapy cohort using an active comparator new-user design.

Target RWE researchers applied NCOs to a real-world comparative analysis of patients initiating lipid-lowering therapies, demonstrating how NCO balance and imbalance can be used to gauge confounding control success before primary outcomes are analyzed.

Validating NCO utility in a large active-comparator lipid study demonstrates that Target RWE's NCO-based validity checking can reliably detect confounding structure, providing pharma partners with a credible bias-assessment tool for regulatory submissions.

NCO validation in lipid-lowering comparative effectiveness for regulatory-grade bias assessment, Active comparator new-user design with NCO as validity check for cardiovascular drug programs