Reference:ICH ICH E9 Guideline 1998 4.5: Difference between revisions
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| | |has_document=Document:ICH ICH E9 Guideline 1998 | ||
| | |module=6 | ||
| | |unit=6.1.2 | ||
| | |scope=HM | ||
| | |doc_part=4.5 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00303-Int-lan ++ TAG-00287-Sto-pre ++ TAG-00038-Ear-tig ++ TAG-00329-Saf-lne | |||
|tags_display=[[Glossary:TAG-00303-Int-lan|Interim analysis]], [[Glossary:TAG-00287-Sto-pre|Stopping rules]], [[Glossary:TAG-00038-Ear-tig|Early termination]], [[Glossary:TAG-00329-Saf-lne|Safety]] | |||
|comment=Interim analysis and early stopping rules | |||
|content=4.5 Interim Analysis and Early Stopping | |||
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4.5 Interim Analysis and Early Stopping | |||
An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial. | An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial. | ||
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The execution of an interim analysis should be a completely confidential process because unblinded data and results are potentially involved. | The execution of an interim analysis should be a completely confidential process because unblinded data and results are potentially involved. | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:50, 16 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 6 — Unit 6.1.2 |
| Scope | HM |
| Document part | 4.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Interim analysis, Stopping rules, Early termination, Safety |
Content
4.5 Interim Analysis and Early Stopping An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial.
Because the number, methods and consequences of these comparisons affect the interpretation of the trial, all interim analyses should be carefully planned in advance and described in the protocol. Special circumstances may dictate the need for an interim analysis that was not defined at the start of a trial. [...] The stopping guidelines and their properties should be clearly described in the protocol or amendments. The potential effects of early stopping on the analysis of other important variables should also be considered. [...] The execution of an interim analysis should be a completely confidential process because unblinded data and results are potentially involved. [...]
