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This chapter provides a comprehensive overview of global initiatives to implement the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9(R1) guideline and its estimand framework across diverse therapeutic areas and statistical disciplines. It highlights the work of seven international working groups, each contributing to the refinement and practical application of the estimand framework in clinical trials. This chapter summarizes the background, objectives, and main activities of each working group. Key initiatives such as the publication of white papers, development of best practices, and engagement with regulatory bodies are discussed, emphasizing the importance of interdisciplinary collaboration. This chapter also highlights how these working groups have fostered global communication through seminars, workshops, and collaborative publications, including the development of the Drug Information Association’s (DIA) Estimand Bluebook in Chinese, which forms the basis of this book. This chapter underscores the ongoing efforts to ensure accurate interpretation and implementation of the estimand framework to enhance the quality and efficiency of clinical trials worldwide as new concepts, methodologies, and guidelines continue to emerge.

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Global Initiatives Since the Release of ICH E9(R1)

  • 章节

  • 发表日期：

    2025年

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  • Jingjun Qiu,
  • Hans Ulrich Burger,
  • Paul Delmar,
  • Evgeny Degtyarev,
  • Christine Fletcher,
  • Elena Polverejan,
  • Chris Price,
  • Stephen J. Ruberg,
  • Kaspar Rufibach,
  • Nikolaos Sfikas,
  • Lori Van Meter,
  • Siyue Wang

摘要

This chapter provides a comprehensive overview of global initiatives to implement the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9(R1) guideline and its estimand framework across diverse therapeutic areas and statistical disciplines. It highlights the work of seven international working groups, each contributing to the refinement and practical application of the estimand framework in clinical trials. This chapter summarizes the background, objectives, and main activities of each working group. Key initiatives such as the publication of white papers, development of best practices, and engagement with regulatory bodies are discussed, emphasizing the importance of interdisciplinary collaboration. This chapter also highlights how these working groups have fostered global communication through seminars, workshops, and collaborative publications, including the development of the Drug Information Association’s (DIA) Estimand Bluebook in Chinese, which forms the basis of this book. This chapter underscores the ongoing efforts to ensure accurate interpretation and implementation of the estimand framework to enhance the quality and efficiency of clinical trials worldwide as new concepts, methodologies, and guidelines continue to emerge.