Evaluating hybrid controls methodology in early-phase oncology trials: a simulation study based on the MORPHEUS-UC trial
早期肿瘤试验混合对照方法评估:基于MORPHEUS-UC的模拟研究
Phase Ib/II oncology trials, despite their small sample sizes, aim to provide information for optimal internal company decision-making concerning novel drug development. Hybrid controls (a combination of the current control arm and controls from one or more sources of historical trial data [HTD]) can be used to increase the statistical precision. Here we assess combining two sources of Roche HTD to construct a hybrid control in targeted therapy for decision-making via an…