The European Union Clinical Trials Register (EU-CTR) has been recognized as one of the primary registries for the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), according to PharmaTimes.
That means the information on EU-CTR, made public last March more than a year later than planned, will be available through the ICTRP web-based portal by the end of 2011, once the technical processes for data transfer are complete.
Set up by the WHO in 2006, the International Clinical Trials Registry Platform allows access to a range of information from different clinical trial registers around the world. With primary register status, data can be submitted directly to the WHO’s clinical trial search portal.
The EU Clinical Trials Register draws on information from EudraCT, the EU’s clinical trials database, giving the general public access to information on clinical trials authorized in the European Union Member States as well as Iceland, Liechtenstein and Norway.
EU-CTR also permits searches on trials approved outside the European Union where these are part of an EU paediatric investigation plan. Unlike ClinicalTrials.gov, the public online registry run by the US National Institutes of Health, the European register does not yet include summaries of clinical trial results.
According to the EMA, which manages and hosts the European Union Clinical Trials Register, primary register status with ICTRP is “an endorsement of EU-CTR’s importance for potential clinical-trial participants as well as sponsors, researchers, ethics committees and policymakers.”
The EMA 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, it noted.
While facilitating public access to information on clinical trials is “an ethical responsibility,” ICTRP also offers “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,” commented Dr Marie-Charlotte Bouësseau, co-coordinator of the WHO trials portal.
Moreover, WHO recognition of EU-CTR will make life easier for authors submitting articles on their clinical trials for publication in scientific journals, the EMA added.
The International Committee of Medical Journal Registers requires studies to be registered prospectively in a public clinical trial register before articles on the trials can be accepted for publication.
“This will benefit EU researchers, who will now be able to apply for clinical trial authorization in the EU and achieve registration in a single process,” the EMA stated.
Launching EU-CTR as a public register, the agency said publication of results summaries would “require a major upgrade to the existing system.” Starting that would depend on finalization of a draft guideline published by the European Commission, as well as availability of budget and resources.
The aim is to introduce the summary results feature on the EU register in late 2012.