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Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interest-and by carefully accounting for intercurrent events-the framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs. |
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