Leveraging External Data for Testing Experimental Therapies with Biomarker Interactions in Randomized Clinical Trials
利用外部数据检验随机临床试验中的生物标志物交互效应
In oncology the efficacy of novel therapeutics often differs across patient subgroups, and these variations are difficult to predict during the initial phases of the drug development process. The relation between the power of randomized clinical trials and heterogeneous treatment effects has been discussed by several authors. In particular, false negative results are likely to occur when the treatment effects concentrate in a subpopulation but the study design did not…