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