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Purpose
Use of real‐world data (RWD) for external controls added to single‐arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to inherent differences in the data‐generating mechanisms, biases can arise. This paper aims to illustrate how to use quantitative bias analysis (QBA).
Methods
Advanced non‐small cell lung cancer (NSCLC) serves as an example, where many small subsets...