The European Medicines Agency has launched an online registry which, for the first time, gives the public access to information on interventional clinical trials in the European Union that heretofore has only been available to the regulatory authorities in the member states.

The new registry can be found at www.clinicaltrialsregister.eu. It includes information on trials that have been authorised in the 27 EU member states as well as in Iceland, Liechtenstein and Norway.

Information in the new public database comes from EudraCT (European Union Drug Regulating Authorities Clinical Trials) which is the confidential database on clinical trials maintained by the national European regulatory authorities.

The new registry will make most, but not all, of the EudraCT information public. Clinical trial results will not, initially, be made available. However, the European Commission is currently consulting stakeholders about making a summary of trial results public as well.

Information in the new registry will include clinical trial design, sponsor, the type of medicine under investigation, the therapeutic indication and well as the status of the trial.

EudraCT was set up in 2004 to enable the national regulatory authorities in the EU to keep one another informed about clinical trial activity. Unlike in the US, where clinical trials are authorised and monitored by the US Food and Drug Administration, there is no central authority in Europe overseeing this activity. Rather, trials are authorised country-by-country by the national regulators. The need for the national regulators to share information is underscored by the fact that many trials, particularly in oncology, are multi-centre, which means that they take place in more than one European country.

The information in EudraCT is supplied by the companies seeking approval to start trials. This information is a component of the companies’ clinical applications to the national regulators.

The new European public registry complements the clinicaltrials.gov trial registry in the US which is run by the US National Institutes of Health (NIH). The clinicaltrials.gov trial registry, which has been in operation for more than a decade, has information on more than 100,000 clinical studies, according to the NIH.

Published with kind permission of MedNous