4 September 2017

The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.

The ICH E9(R1) Addendum promotes harmonised standards on the choice of estimand in clinical trials and describes an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. The ICH E9(R1) draft Addendum can be downloaded on the Efficacy Guideline page on the ICH website.

You may provide comments on the ICH E9(R1) draft Addendum document by e-mailing the ICH Secretariat. More details under the Public Consultation page.

Note that stakeholders from ICH Regions are encouraged to submit their comments to their respective Regulatory Authorities.