Missing data in confirmatory clinical trials

Current effective version

PDF icon Revision 1 - Adopted guideline

Reference numberCPMP/EWP/1776/99 Rev. 1
Effective from01/01/2011
KeywordsBaseline observation carried forward (BOCF), generalised estimating equations (GEE), last observation carried forward (LOCF), missing at random (MAR), missing completely at random (MCAR), missing data, mixed models for repeated measures (MMRM), missing not at random (MNAR), pattern mixture models
DescriptionThis document explains how the presence of missing data in confirmatory clinical trials should be addressed and reported in a dossier submitted for regulatory review. It provides an insight into the regulatory standards that will be used to assess confirmatory clinical trials with missing data.

Document history

Revision 1

Current version

PDF icon Adopted guideline


PDF icon Draft guideline


PDF icon Draft guideline

In operation: 01/01/2012–present


Published: 13/04/2009


Published: 13/12/2007

First version PDF icon Points to consider Published: 15/11/2001

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