ICH E9(R1)Addendum: Statistical Principles for Clinical Trials

Title:
ICH E9(R1)Addendum: Statistical Principles for Clinical Trials
Short Title:
Estimands and Sensitivity Analysis in Clinical Trials

https://www.gmp-compliance.org/files/guidemgr/E9-R1_Step4_Guideline_2019_1203.pdf

Origin/Publisher:

ICH

Document Type:
Guideline
Content:
The ICH E9(R1) Addendum presents a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis and interpretation, as well as between sponsor and regulator regarding the treatment effect(s) of interest that a clinical trial should address.

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