Missing data in confirmatory clinical trials

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Current effective version

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

Adopted guideline

Draft guideline

Draft guideline

In operation: 01/01/2012–present

Published: 13/04/2009

Published: 13/12/2007

First versionPoints to considerPublished: 15/11/2001

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