WHO adds EU registry to clinical trial database

By Alexandria Pesic

- Last updated on GMT

Related tags Clinical trials Food and drug administration Clinical trial Pharmaceutical industry

The EU Clinical Trials Register (EU-CTR) has been formally recognised by the World Health Organization (WHO) as one of the primary registries for its International Clinical Trials Registry Platform (ICTRP).

ICTRP is designed to ensure those involved in making healthcare decisions have full access to research, ensuring transparency and, so say the WHO, 'strengthening the validity and value of the scientific evidence base.'

The WHO's recognition means its information will be available through the EU-CTR by the end of the year, once various technical details relating to the transfer of information are finalised.

Responding to the news, Marie-Charlotte Bouësseau , coordinator of the ICTRP, said: "The recognition of the EU-CTR as primary registry for ICTRP illustrates the global effort to improve transparency in research activities.

"The WHO and the European Medicines Agency (EMA) are strongly committed to maintaining this effort in close collaboration with all relevant stakeholders."

Information repository

Currently the EU-CTR is both managed and hosted by the EMA, and is a repository of information on clinical trials in the European Economic Area (EEA), as well as those trials conducted outside the EEA that form part of a paediatric investigation plan (PIP). The register was made public in March of this year.

Bouësseau said providing public access to information on clinical trials was an ethical responsibility the EMA took seriously.

"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," she said.

Through the WHO's recognition, the EU-CTR will provide authors with help in submitting articles on clinical trials for publication in scientific journals. Currently the International Committee of Medical Journal Editors (ICMJE) demands that clinical trials be registered prospectively in a public trials register before being approved for publication.

The new development will streamline the approval process, allowing EU researchers to apply for authorisation and register their trials simultaneously.

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