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

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.

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

Current effective version

Points to consider on application with 1.meta-analyses, 2.one pivotal study

AdoptedLegal effective date: 01/05/2001Reference Number: CPMP/EWP/2330/99

Document history

Draft points to consider on validity and interpretation of meta-analyses, and one pivotal study

Draft: consultation closedReference Number: CPMP/EWP/2330/99