Comparison of different sample space ordering method in overestimation of efficacy correction during clinical trial interim analysis
Aim:To compare the performance of stagewise(SW)ordering,likelihood ratio(LR)ordering,and maxi-mum likelihood estimator(MLE)ordering in correcting overestimation of efficacy in different scenarios in group sequential design interim analysis.Methods:Normal distributed quantitative simulation datasets were generated using SAS 9.4.After the simulated interim analysis,the median unbiased estimator(MUE)and its lower limit of 95%confidence interval(CI)were used to assess the performance of SW ordering,LR ordering and MLE ordering.Finally,a randomized controlled trial was used as a validation.Results:Compared with SW ordering,the MUE and its lower limit of 95%CI of LR ordering and MLE ordering were closer to the true intergroup effect.Conclusion:LR ordering and MLE ordering could obtain better cor-rection efficacy than SW ordering during clinical trial interim analysis in normally distributed data.
clinical trialinterim analysissample space orderingoverestimation of efficacy correction
国家科技期刊平台
NSTL
万方数据
