Interim Design Modifications in Time-to-Event Studies
事件时间研究中的期中设计修改
We propose a flexible method for interim design modifications in time-to-event studies. With this method, it is possible to inspect the data at any time during the course of the study, without the need for prespecification of a learning phase, and to make certain types of design modifications depending on the interim data without compromising the Type I error risk. The method can be applied to studies designed with a conventional statistical test, fixed sample, or group…