Reference:ICH ICH E8 Guideline R1 (2021) 5.6: Difference between revisions
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| | |has_document=Document:ICH ICH E8 Guideline R1 (2021) | ||
| | |module=3 | ||
| | |unit=3.3.1 | ||
| | |scope=HM | ||
| | |doc_part=5.6 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00123-Bli-ppe ++ TAG-00314-Unb-ung ++ TAG-00303-Int-lan ++ TAG-00056-Bio-tik | |||
|tags_display=[[Glossary:TAG-00123-Bli-ppe|Blinding]], [[Glossary:TAG-00314-Unb-ung|Unblinding]], [[Glossary:TAG-00303-Int-lan|Interim analysis]], [[Glossary:TAG-00056-Bio-tik|Biostatistics]] | |||
|comment=Statistical analysis finalised before unblinding in double-blind studies | |||
|content=5.6 Statistical Analysis | |||
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5.6 Statistical Analysis | |||
[…] | […] | ||
For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefore, if a study includes one or more interim analyses, the planned statistical analysis should not be changed after an interim analysis that involves unblinding. For open-label and single-blind studies, details pertaining to the primary and important secondary analyses would ideally be finalised before the first participant is randomised or allocated to study intervention. | For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefore, if a study includes one or more interim analyses, the planned statistical analysis should not be changed after an interim analysis that involves unblinding. For open-label and single-blind studies, details pertaining to the primary and important secondary analyses would ideally be finalised before the first participant is randomised or allocated to study intervention. | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.3.1 |
| Scope | HM |
| Document part | 5.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Blinding, Unblinding, Interim analysis, Biostatistics |
Content
5.6 Statistical Analysis […] For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefore, if a study includes one or more interim analyses, the planned statistical analysis should not be changed after an interim analysis that involves unblinding. For open-label and single-blind studies, details pertaining to the primary and important secondary analyses would ideally be finalised before the first participant is randomised or allocated to study intervention. [...]
