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.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Implementation of the Estimand Thinking Process Through Multidisciplinary Collaborations

  • Elena Polverejan,
  • Bharani Dharan,
  • Juan Zhang

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.