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

  • Email
  • Help
Current effective version

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.  

Document history

First version

Current version

Points to consider

Draft points to consider

Published: 31/05/2001

Published: 19/10/2000

Related content

How helpful is this page?

Average rating:

 Based on 38 ratings

Add your rating:

See all ratings
8 ratings
7 ratings
7 ratings
8 ratings
8 ratings

Tell us more