Current effective version | Points to consider |
Reference number | CPMP/EWP/2330/99 |
Published | 31/05/2001 |
Effective from | 31/05/2001 |
Keywords | Meta-analysis, one pivotal trial, internal validity, external validity, selection bias, heterogeneity, extrapolation, assessment of consistency, multi-regional clinical trials, centre, interaction test, level of evidence for drug licensing |
Description | This document provides guidance on two topics: the use of meta-analysis and the use of only a single pivotal study in phase III clinical development. |
Document history
First version Current version | Published: 31/05/2001 Published: 19/10/2000 |
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