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The ICH E9 (R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials (Step 4)” was finalized in November 2019 and subsequently implemented by many regulatory agencies, including FDA (May 2021). This article is based on a session organized to cover experience implementing the estimand framework, including its use, impact on drug/biologic development, common challenges and ways to address them, as well as keys to productive interdisciplinary collaboration.

Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation