Missing data in confirmatory clinical trials - Scientific guideline
Table of contents
This 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.
Keywords: Baseline 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
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Draft guideline on missing data in confirmatory clinical trials (PDF/116.6 KB)
Draft: consultation closed
First published: 13/04/2009
Last updated: 13/04/2009
CPMP/EWP/1776/99 Rev. 1 Corr* -
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Recommendation for the revision of the points to consider on missing data (CPMP/EWP/1776/99) (PDF/34.72 KB)
Draft: consultation closed
First published: 13/12/2007
Last updated: 13/12/2007
EMEA/CHMP/EWP/439980/2007 -
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Points to consider on missing data (PDF/37.82 KB)
Adopted
First published: 15/11/2001
Last updated: 15/11/2001
CPMP/EWP/1776/99