Missing data in confirmatory clinical trials - Scientific guideline

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

Current effective version

Guideline on missing data in confirmatory clinical trials

AdoptedLegal effective date: 01/01/2011Reference Number: EMA/CPMP/EWP/1776/99 Rev. 1

Document history

Draft guideline on missing data in confirmatory clinical trials

Draft: consultation closedReference Number: CPMP/EWP/1776/99 Rev. 1 Corr*

Recommendation for the revision of the points to consider on missing data (CPMP/EWP/1776/99)

Draft: consultation closedReference Number: EMEA/CHMP/EWP/439980/2007

Points to consider on missing data

AdoptedReference Number: CPMP/EWP/1776/99