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 individu...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.展开更多
文摘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.
