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The International Council for Harmonisation (ICH) develops guidelines to standardize pharmaceutical development, strengthen global regulatory practices, and enhance the reliability of clinical trials. Among these, the ICH E9(R1) guideline, published in 2019, provides a structured framework for aligning clinical trial objectives, design, data collection, and analysis approaches. Given its broad relevance, the ICH E9(R1) guideline is closely related to other ICH guidelines. This chapter focuses on the relationship between the estimand framework in the ICH E9(R1) guideline and other ICH guidelines, including ICH E8(R1), ICH M11, and ICH E20, along with earlier ICH guidelines predating the formal introduction of the estimand framework The discussion highlights how these guidelines either align with the principles of the estimand framework or may be influenced by the ICH E9(R1) guideline during their implementation. Understanding these interconnections can help harmonize global practices, refine the scientific and statistical rigor of clinical trials, improve trial transparency and reliability, and ensure high-quality, evidence-based regulatory decisions.

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ICH Guidelines and Their Relationship to the Estimand Framework

  • 章节

  • 发表日期：

    2025年

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  • Cui Xiong,
  • Frank Bretz,
  • Jiawei Wei,
  • Byron Jones,
  • Christine Fletcher,
  • William W. Wang,
  • Jun Wang,
  • Luyan Dai,
  • Jielai Xia,
  • Jianhong Pan

摘要

The International Council for Harmonisation (ICH) develops guidelines to standardize pharmaceutical development, strengthen global regulatory practices, and enhance the reliability of clinical trials. Among these, the ICH E9(R1) guideline, published in 2019, provides a structured framework for aligning clinical trial objectives, design, data collection, and analysis approaches. Given its broad relevance, the ICH E9(R1) guideline is closely related to other ICH guidelines. This chapter focuses on the relationship between the estimand framework in the ICH E9(R1) guideline and other ICH guidelines, including ICH E8(R1), ICH M11, and ICH E20, along with earlier ICH guidelines predating the formal introduction of the estimand framework The discussion highlights how these guidelines either align with the principles of the estimand framework or may be influenced by the ICH E9(R1) guideline during their implementation. Understanding these interconnections can help harmonize global practices, refine the scientific and statistical rigor of clinical trials, improve trial transparency and reliability, and ensure high-quality, evidence-based regulatory decisions.