What ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials requires
This addendum requires clinical trial sponsors to precisely define the 'estimand' (the treatment effect to be estimated) using a structured framework and conduct sensitivity analyses to assess the robustness of results. This framework, detailed in Section A.3, applies to all clinical trials intended for regulatory submission to ensure alignment between trial objectives, design, conduct, and analysis.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf
SHA-256 integrity: c31b44da6a346d4fc40144659eaee4a64e25d01b50a7e70c2d995df93dc6d66c
Primary Citations — 6 traced to source
- ICH E9(R1) Addendum, Section A.3: The Estimand
- ICH E9(R1) Addendum, Section A.4: Intercurrent Events
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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