Implementation of the Estimand Thinking Process Through Multidisciplinary Collaborations
摘要
The implementation of the estimand framework can be facilitated effectively by following the steps of an estimand thinking process in line with the principles laid out in the ICH E9(R1) guideline. This process requires collaborative efforts from multidisciplinary teams, including statisticians, clinicians, and professionals from other groups such as regulatory affairs and clinical operations. This chapter describes the seven steps of the estimand thinking process, related to trial objectives, intercurrent events, clinical questions, estimands, trial design, analysis approaches, and documentation. These steps will be illustrated by a practical application from a hypothetical case study on major depressive disorder (MDD). The description of the estimand thinking process and the case study is intended to be a practical aid to clinical trial teams in applying the estimand framework to clinical trials. This chapter also highlights the importance of multidisciplinary collaborations in implementing the estimand thinking process.