ICH E9 statistical principles for clinical trials - Scientific guideline
Table of contents
This document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development. It also assists with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.
The addendum provides clarification on some of the concepts explained in ICH E9. It presents a structured framework for clinical trial planning, conduct, data collection and interpretation of data analyses. The addendum also refines the role of sensitivity analysis to explore robustness of conclusions from the main statistical analysis, both aligned to the same estimand.
Keywords: Statistical methodology, clinical trial design.
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ICH: E 9: Statistical principles for clinical trials - Step 5 (PDF/324.57 KB)
Adopted
First published: 01/09/1998
Last updated: 01/09/1998
Legal effective date: 01/09/1998
CPMP/ICH/363/96 -
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ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials - Step 5 (PDF/286.57 KB)
Adopted
First published: 18/02/2020
Legal effective date: 30/07/2020
EMA/CHMP/ICH/436221/2017
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ICH: E 9: Statistical principles for clinical trials - Step 5 (PDF/324.57 KB)
Adopted
First published: 01/09/1998
Last updated: 01/09/1998
Legal effective date: 01/09/1998
CPMP/ICH/363/96 -
List item
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials - Step 5 (PDF/286.57 KB)
Adopted
First published: 18/02/2020
Legal effective date: 30/07/2020
EMA/CHMP/ICH/436221/2017 -
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Draft ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, step 2b - Revision 1 (PDF/381.35 KB)
Draft: consultation closed
First published: 31/08/2017
Last updated: 31/08/2017
Consultation dates: 31/08/2017 to 28/02/2018
EMA/CHMP/ICH/436221/2017 -
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Overview of comments received on draft ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017) (PDF/927.98 KB)
First published: 26/04/2018
Last updated: 26/04/2018
EMA/744060/2017