Reference:ICH ICH E9 Guideline 1998 4.5

Document Information

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

Scope	HM
Document part	4.5
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Interim analysis and early stopping rules

Text

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. [...]