A Non-Parametric Sensitivity Analysis for Bounding Bias in Hybrid Control Trials
混合对照试验中偏差界定的非参数敏感性分析
We study hybrid control trials (HCTs), in which a randomized controlled trial (RCT) is augmented with external control patients. Existing approaches for HCTs typically assume conditional exchangeability of the concurrent and external controls to identify trial-specific effects. When violated, this can induce substantial unquantified bias, which in turn limits the acceptability of HCTs in regulatory settings. We treat violations of mean exchangeability as omitted variable…