Group sequential methods for interim monitoring of randomized clinical trials with time-lagged outcome
结局延迟随机临床试验期中监测的组序贯方法
The primary analysis in two-arm clinical trials usually involves inference on a scalar treatment effect parameter; e.g., depending on the outcome, the difference of treatment-specific means, risk difference, risk ratio, or odds ratio. Most clinical trials are monitored for the possibility of early stopping. Because ordinarily the outcome on any given subject can be ascertained only after some time lag, at the time of an interim analysis, among the subjects already enrolled,…