ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

About this guideline

Adopted by the TGA: 1 August 2025

Overseas effective date: 30/07/2020

Categories: Clinical efficacy and safety | Biostatistics

ICH | efficacy

TGA annotations: This guideline does not apply to listed medicines, assessed listed medicines and registered complementary medicines.

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For more information see International scientific guidelines adopted in Australia.