How to implement the‘one patient,one vote’principle under the framework of estimand  

作　　者：Naitee Ting 

机构地区：[1]Department of Biostatistics and Data Sciences,Boehringer Ingelheim Pharmaceuticals,Inc,Danbury,CT,USA

出　　处：《Statistical Theory and Related Fields》2023年第3期202-212,共11页统计理论及其应用（英文）

摘　　要：The scientific foundation of a modern clinical trial is randomization–each patient is randomized to a treatment group,and statistical comparisons are made between treatment groups.Because the study units are individual patients,this‘one patient,one vote’principle needs to be fol-lowed–bothinstudydesignandindataanalysis.Fromthephysicians’pointofview,eachpatient is equally important,and they need to be treated equally in data analysis.It is critical that statisti-cal analysis should respect design and study design is based on randomization.Hence from both statistical and medical points of view,data analysis needs to follow this‘one patient,one vote’principle.Under ICH E9(R1),five strategies are recommended to establish‘estimand’.This paper discusses how to implement these strategies using the‘one patient,one vote’principle.

关 键 词：Estimand LOCF one patient one vote 

分 类 号：R31[医药卫生—基础医学]