Reference:ICH ICH E9 Guideline 1998 III: Difference between revisions
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| | | [[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00142-Mul-ent|Multicentre trial]], [[Glossary:TAG-00056-Bio-tik|Biostatistics]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E9 Guideline 1998 |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E9 Guideline |
| Version / Revision | 1998 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.7 |
| Scope | HM |
| Document part | III |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Study design, Multicentre trial, Biostatistics |
| Comment | Trial design configurations: parallel, crossover, factorial |
Content
III. TRIAL DESIGN CONSIDERATIONS 3.1 Design Configuration 3.1.1 Parallel Group Design […] 3.1.2 Crossover Design […] 3.1.3 Factorial Designs […] 3.2 Multicentre Trials […] 3.3 Type of Comparison 3.3.1 Trials to Show Superiority […] 3.3.2 Trials to Show Equivalence or Non-inferiority [...] 3.3.3 Trials to Show Dose-response Relationship [...] 3.4 Group Sequential Designs [...] 3.5 Sample Size [...] 3.6 Data Capture and Processing [...]
