Application with 1. Meta-analyses; 2. One pivotal study

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Points to consider

Reference numberCPMP/EWP/2330/99
Effective from31/05/2001
KeywordsMeta-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
DescriptionThis 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.  

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Published: 31/05/2001

Published: 19/10/2000

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