Information on clinical trials accessible through new online EU register
For the first time, Europeans have access to information on clinical trials for medicines authorised across Europe, thanks to a new database set up by the European Medicines Agency (EMA). The EU Clinical Trials Register, launched on 22 March, allows the public to search for information on interventional clinical trials for medicines authorised in the 27 EU Member States as well as Iceland, Liechtenstein and Norway. The database also allows users to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan. The register was put together after extensive consultation with stakeholders, including patients and healthcare professionals, to ensure that their needs were taken into account when designing the register. 'We welcome the launch of the EU Clinical Trials Register. It increases transparency of medical research and will make it much easier for patients to find information about clinical trials taking place in Europe,' said Lise Murphy, co-chair of the EMA's Working Party with Patients' and Consumers' Organisations. The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. The information is provided by the sponsor of the clinical trial, and forms part of the application to a national medicines regulatory authority for authorisation to conduct a trial. The information from the sponsor is then loaded into the EudraCT database by the national medicines regulatory authority. The authority adds to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. Information on third-country trials that are listed in a paediatric investigation plan (PIP) is provided by the PIP addressee directly, via the EMA, to the system. Data which was entered into the EudraCT database between 1 May 2004 and the release of version 8.0 of the EudraCT database on 10 March 2011 will be gradually published online from March 2011. The EMA now plan to further develop the system to ensure it becomes as valuable and useful a resource as possible for patients across the EU. It is essential that the EMA continues to work with stakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and comprehensiveness of data, and improving the search functionality. There are also future plans to include the publication of summaries of clinical trial results, on which draft guidance has already been published for consultation by the European Commission. However, the publication of trial results summaries will require a major upgrade to the existing system, which will depend on the finalisation of guidelines and the availability of budget and resources. The EMA, located in London, is a decentralised agency of the EU. It is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU. Protecting and promoting public and animal health through the evaluation and supervision of medicines for human and veterinary use is its main responsibility. The Agency aims to work closely with all its partners to build the best possible regulatory system for medicines for Europe and to protect the health of its citizens. The EMA is the central 'hub' of the European medicines network: it is made up of over 40 national competent authorities in 30 EU and European Economic Area-European Free Trade Association (EEA-EFTA) countries, as well as the European Commission, the European Parliament and a number of other decentralised EU agencies.For more information, please visit: European Medicines Agency:http://www.ema.europa.euEU Clinical Trials Register:https://www.clinicaltrialsregister.eu/