ICH guideline
ICH E9(R1): Addendum: Statistical Principles for Clinical Trials
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E9(R1) |
|---|---|
| Title | Addendum: Statistical Principles for Clinical Trials |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | 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… |
| File | E9(R1) Training Materials PDF |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- E9(R1) Training Materials PDF Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.