EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making.

ABSTRACT:

Introduction

A review of European Union (EU)-funded initiatives linked to 'Real World Evidence' (RWE) was performed to determine whether their outputs could be used for the generation of real-world data able to support the European Medicines Agency (EMA)'s regulatory decision-making on medicines.

Method

The initiatives were identified from publicly available websites. Their topics were categorised into five areas: 'Data source', 'Methodology', 'Governance model', 'Analytical model' and 'Infrastructure'. To assess their immediate relevance for medicines evaluation, their therapeutic areas were compared with the products recommended for EU approval in 2016 and those included in the EMA pharmaceutical business pipeline.

Results

Of 171 originally identified EU-funded init

SUBMITTER: Plueschke K 

PROVIDER: S-EPMC6009620 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature