Simulation study design
cancer
CANCER, EVENT
In order to evaluate the performance of the proposed method based on CSH in estimating treatment effect, the simulation study was designed with different scenarios. This was to compare the results of the proposed method with naïve methods (ITT and PP) in the presence of competing event. To understand the verification of the proposed method in CR, the event type was ignored but different causes of event were combined into a single event or composite endpoint, so called ITT-com, PPcen-com and RPSFT-com. The switching was only allowed from the standard to the experimental treatment. In PP method, all switched patients were considered censored at the time of switching (i.e. PP-cen method). Then, the performance of adjusting methods were assessed by criteria such as censoring percentage, coverage percentage, relative bias percentage and mean square error. The setting of this simulation study mimics a real cancer clinical trial in the presence of CR. All data management and analytical procedures were performed in the statistical programing software R version 3.5.3. Details are given below.