Reference:ICH ICH E8 Guideline R1 (2021) 5.6: Difference between revisions
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| 5.6 | | 5.6 | ||
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| EN | | EN | ||
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| Florian Adragna | | Florian Adragna | ||
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| Statistical analysis finalised before unblinding in double-blind studies | | Statistical analysis finalised before unblinding in double-blind studies | ||
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== | == Content == | ||
5.6 Statistical Analysis | 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. | ||
[...] | [...] | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | HM |
| Document part | 5.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Statistical analysis finalised before unblinding in double-blind studies |
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. [...]
