ICH guideline
ICH E10: Choice of Control Group and Related Issues in Clinical Trials
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E10 |
|---|---|
| Title | Choice of Control Group and Related Issues in Clinical Trials |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH harmonised Guideline was finalised under Step 4 in July 2000. This document addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay sensitivity problem in active control equivalence… |
| File | E10 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- E10 Guideline 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.