EU Clinical Trials Register recognised as 'primary registry' of WHO's International Clinical Trials Registry Platform
The World Health Organization (WHO) has recognised the European Union Clinical Trials Register (EU-CTR) as one of the primary registries for its International Clinical Trials Registry Platform (ICTRP).
ICTRP is a web-based portal that allows access to a wide range of information from different clinical-trial registers from across the world.
EU-CTR's recognition means that its information will be available through this portal by the end of the year, once the technical processes to allow transfer of the information are complete. It is also an endorsement of EU-CTR's importance for potential clinical-trial participants as well as sponsors, researchers, ethics committees and policymakers.
EU-CTR, which is managed and hosted by the European Medicines Agency, contains information on clinical trials in the European Economic Area (EEA), as well as information on clinical trials conducted outside the EEA that form part of a paediatric investigation plan (PIP). The Agency made the register public on 22 March 2011.
The Agency has been working towards recognition of EU-CTR with the WHO for a number of years, with the agreement and support of the medicines regulatory authorities in EEA Member States.
"The recognition of EU-CTR as primary registry for ICTRP illustrates the global effort to improve transparency in research activities," said Dr Marie-Charlotte Bouësseau, co-ordinator of ICTRP. "The WHO and the Agency are strongly committed to maintaining this effort, in close collaboration with all relevant stakeholders.
"Facilitating public access to information on clinical trials is an ethical responsibility.
"ICTRP is also a very useful tool for the analysis of ongoing health research and should facilitate the better use of evidence in public-health decision-making processes."
EU-CTR's recognition will help authors submitting articles on their clinical trials for publication in scientific journals. The International Committee of Medical Journal Editors (ICMJE) requires clinical trials to be registered prospectively in a public clinical trial register before accepting articles on the trials for publication.
This will benefit EU researchers, who will now be able to apply for clinical trial authorisation in the EU and achieve registration in a single process.