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Training Course: ICH for Statisticians - Part 3: Review of ICH E9

19 November 2019

Chrissie Fletcher

This session covers an overview of ICH E9 (Statistical Principles for Clinical Trials) and E9 (R1) Addendum (Estimands and Sensitivity Analysis in Clinical Trials). 
ICH E9 sets out the principles of statistical methodology applied to clinical trials for marketing applications submitted in the ICH regions. The principles outlined in this guidance are primarily relevant to clinical trials conducted in the later phases of development, many of which are confirmatory trials of efficacy. An addendum was proposed to provide clarification on E9 and an update on the choice of estimand in clinical trials to describe an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. The Addendum is proposed to focus on statistical principles related to estimands and sensitivity analysis, not on the use or acceptability of specific statistical procedures or methods. While a variety of mid-stage and late-stage clinical trials may be in scope, the primary focus of the Addendum will be on confirmatory clinical trials.

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