Key result
The ICH E9(R1) Addendum estimand framework has played a critical role in drug and biological product development and review over the past five years.
Why the study?
Since the finalization of the ICH E9 (R1) Addendum in 2019, the estimand framework has played a critical role in drug and biological product development and review, warranting a summary of implementation experiences and next steps.
This review highlights the critical role and successful implementation of the estimand framework in drug development since the ICH E9(R1) Addendum.
Answers are grounded in this paper and cite their sources.
Streamlines industry-regulator dialogue on trial objectives; extends five years of estimand implementation experience.
Since the finalization of the ICH E9 (R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials (Step 4)” in 2019, the implementation of the estimand framework has been playing a critical role in the drug and biological product development and review. This article summarizes pharmaceutical industry and regulatory experiences with the estimand framework over the past five years, offers unique insights into successful estimand framework implementation, and highlights perspectives on key next steps.
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Ionan et al. (2025) reported a review. Estimand framework was evaluated. The ICH E9(R1) Addendum estimand framework has played a critical role in drug and biological product development and review over the past five years.
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