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EU register of clinical trials launched

The EC and the European Medicines Agency has launched a database of thousands of trials that are underway in Europe

EU citizens will have access to information on the thousands of authorised pharmaceutical clinical trials that are underway in the region, following the launch of an online register by the European Medicines Agency (EMA) and the EC.

The aim of the register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials.

The clinical register contains information about clinical trials authorised in the EU, whether they take place in one member state or several. It includes trials conducted in industry and research institutions. The information is rendered once the trial has been authorised.

It follows the EMA's decision to relax its policy on access to documents related to medicines for human and veterinary use in response to increasing public demand for more openness and transparency.

John Dalli, European commissioner for health and consumer policy, said: "It is good news for patients as it will allow them to get easier information about clinical trials going on in the EU, possibly giving access to important new treatment. It is also of great interest to healthcare professionals and carers, the research community and industry."

The EMA is responsible for the day-to-day management of the register. The organisation or company responsible for sponsoring the clinical trial provides and updates the information in the register via the national authority of the country, or countries, in which it is being conducted.

The register is part of the overarching EU public database EudraPharm, which also contains centralised information on medicines authorised by the EU.

The register has been welcomed by industry groups, including EuropaBio and BioIndustry Association. Nathalie Moll, EuropaBio secretary general, said: "Crucial information on trials for innovative and potentially life-saving therapies are now available, bringing renewed hope to patients. It also marks a clear move toward further transparency in the field of medical research across the Europe."

Every year more than 4,000 clinical trials are performed in the EU involving about 400,000 patients.

The clinical trial register is available at: www.clinicaltrialsregister.eu

24th March 2011

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