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

Titel:
ICH E9(R1)Addendum: Statistical Principles for Clinical Trials
Kurztitel:
Estimands and Sensitivity Analysis in Clinical Trials
Internet:

https://www.gmp-navigator.com/files/guidemgr/E9-R1_Step4_Guideline_2019_1203.pdf

Herkunft/Verlag:

ICH

Dokumentenart:
Guideline
Inhalt:
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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