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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Regulatory Science

Background:

  • The International Council for Harmonisation (ICH) guideline E9 on Statistical Principles for Clinical Trials was established in 1998.
  • An addendum, ICH E9 (R1), focusing on estimands and sensitivity analyses, was finalized in 2019.
  • The estimand framework aims to improve clarity and consistency in defining trial objectives.

Purpose of the Study:

  • To review progress in implementing the estimand framework since 2018.
  • To provide a refresher on the fundamentals of estimands for clinical research.
  • To discuss ongoing challenges and potential solutions related to estimand application.

Main Methods:

  • Compilation and discussion of relevant articles from Pharmaceutical Statistics.
  • Overview of recent contributions to the estimand framework.
  • Presentation of a personal perspective on the success and challenges of estimands.

Main Results:

  • The estimand framework has seen progress in its implementation within clinical research.
  • Key articles highlight advancements and ongoing discussions on estimands.
  • Areas for further development and refinement have been identified.

Conclusions:

  • The estimand framework represents a significant step forward in enhancing the quality of clinical research.
  • Continued discussion and adaptation are necessary to fully realize the benefits of estimands.
  • Addressing remaining challenges will further solidify the role of estimands in statistical principles for clinical trials.