E9 Statistical Principles for Clinical Trials
The ICH Harmonised Guideline was finalised under Step 4 in February 1998. This document 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.
Date of Step 4: 5 February 1998
Status: Step 5
Guidelines (Click the links below for complete guidelines)
E9(R1) EWG Addendum: Statistical Principles for Clinical Trials
This topic was endorsed by the ICH Steering Committee in October 2014.
The Addendum provides 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. This Addendum focuses on statistical principles related to estimands and sensitivity analysis, not on the use or acceptability of specific statistical procedures or methods. The primary focus of the Addendum is on confirmatory clinical trials.
Date of Step 4: 20 November 2019
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
E9(R1) Step 2 Training Material
*These Guidelines Belongs to ICH website.
ICH E9 Statistical Principles for Clinical Trials Guidelines:
