Researchers who author articles based on clinical trial results can now avoid having to publish the same study in two different public registers.
They can avoid double-registration because the EU Clinical Trials Register has now been recognised by the World Health Organization (WHO’s International Clinical Trials Registry Platform) as a so-called 'primary registry' like its US counterpart ClinicalTrials.gov.
Registry endorsed by editors
WHO's recognition makes the EU Clinical Trials Register compliant with the requirements of the International Committee of Medical Journal Editors (ICMJE), which provides that clinical trials must be registered prospectively in a public clinical trial register before the editors will accept articles on the trials for publication.
It provides overall benefits for EU researchers, who can now apply for clinical trial authorisation in the EU and achieve registration in a public register in a single process.
Benefit depends upon completion of EudraCT form in English
In order to benefit from the change, the application form which is completed at commencement of the trial for the EudraCT database must be in English since the EU Clinical Trials Register retrieves data from EudraCT.
The Danish Health and Medicines Authority advise researchers to keep this in mind as it is a requirement from WHO.
Follow this link to read more about the EU Clinical Trials Register.
Annoucement from EMA
EU Clinical Trials Register information now available through WHO's International Clinical Trials Registry Platform