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Clinical trials register initiated in EU

Thursday, March 24, 2011 01:42 PM

An online register giving the public access to information on clinical trials authorized in the 27 E.U. member states as well as Iceland, Liechtenstein and Norway has been launched by the EMA, according to PharmaTimes.

The E.U. Clinical Trials Register, which draws on information from EudraCT, the E.U.’s clinical trials database, also permits searches on trials approved outside the E.U. where they are part of an E.U. pediatric investigation plan.

It does not yet include summaries of clinical trial results, whose publication will require “a major upgrade to the existing system,” the EMA said.

The register, at https://www.clinicaltrialsregister.eu, is part of EudraPharm, an E.U. public database that provides a centralized source of information on medicines authorized in the E.U., such as details of patient information leaflets.

The EMA is responsible for the day-to-day management of the new register, which incorporates information provided by the sponsor on approved interventional clinical studies of medicines as part of its application to a national regulatory authority to conduct the trial. The national authority loads this information into the EudraCT database and supplements it with the clinical trial approval and relevant ethics committee opinion.

Trials on the register include those conducted by industry and research institutes alike, with the information made public once a clinical study has been authorized. The scope of the Register is information from any pediatric clinical trial and any Phase II-IV adult clinical trial recorded on EudraCT.

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