Two-Stage Design with Sample Size Re-estimation Using gsDesign
使用 gsDesign 进行样本量重估的两阶段设计
The effect size and nuisance parameters needed to appropriately size a clinical trial are generally not adequately understood before a trial begins. Through pre-planned early stopping rules, a conservatively planned group sequential design can effectively adapt the sample size for a clinical trial for a new treatment that is ineffective, very effective or minimally effective. One potential issue with such designs is that a substantial number of patients can be enrolled after…