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The EU Clinical Trials Register is launched today Imprimer
Nouvelles de l'EMA
The EU Clinical Trials Register is launched today by the European Medicines Agency (EMA) !
(https://www.clinicaltrialsregister.eu)


The online registergives for the first time public access to information on interventionalclinical trials for medicinesauthorisedin the 27 EU Member States and Iceland, Liechtenstein and Norway. The databasealsoallows the public to search for information on clinical trials authorised to becarried out outside the EU if these trials are part of apaediatric investigation plan.

The information contained in the EU Clinical Trials RegisterisextractedfromEudraCT, the EU clinical trials database. It isprovided by the sponsor of the clinical trial, and isa component of its application to a national medicinesregulatoryauthority for authorisation to conduct a trial. The information from the sponsor isloadedinto the EudraCTdatabase by the national medicinesregulatoryauthority. The authorityadds to this information the authorisation of the clinical trial and the opinion from the relevant ethicscommittee. Information on third-country trials that are listed in a paediatric investigation plan (PIP) isprovided by the PIP addresseedirectly, via the EMA, to the system.

Throughout the project the Agency workedtogetherwithstakeholders, including patients and healthcareprofessionals, to ensurethattheirneedsweretakenintoaccount, to the extent possible atthis stage, whendesigning the register.

Lise Murphy, co-chair of the Agency'sWorking Party with Patients' and Consumers' Organisations said: "Wewelcome the launch of the EU Clinical Trials Register. It increasestransparency of medicalresearch and willmakeitmucheasier for patients to find information about clinical trials taking place in Europe. We are committed to continue workingwith the EMA to furtherdevelop the system sothatitbecomes a valuable and usefulresource for patients across the EU."

The Agency will continue to workwithstakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and completeness of data, and improving the searchfunctionality. Plans for the future alsoinclude the publication of summaries of clinical trial results, on whichdraft guidance has already been published for consultation by the European Commission. Publication of trial resultssummarieswillrequire a major upgrade to the existing system, the start of whichwilldepend on finalisation of the guideline and availability of budget and resources. Alessandro Camera | Medical Information SectorEuropeanMedicines Agency | 7 WestferryCircus | Canary Wharf | London E14 4HB | United Kingdom Tel. +44 (0)20 7418 8724 | Fax +44 (0)20 7523 7129 | Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir. | www.ema.europa.eu

 
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