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Articles

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

Pages 202-212 | Received 28 Nov 2022, Accepted 30 Dec 2022, Published online: 15 Apr 2023
 

Abstract

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 followed – both in study design and in data analysis. From the physicians' point of view, each patient is equally important, and they need to be treated equally in data analysis. It is critical that statistical 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.

Disclosure statement

No potential conflict of interest was reported by the author(s).