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

Short Title:
Estimands and Sensitivity Analysis in Clinical Trials


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. This 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.

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