New EU online register grants access to information on authorised pharmaceutical clinical trials

The EU Clinical Trials Register was launched by the European Medicines Agency (EMA) on 22 March. This online register will give for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried outside the EU if these trials are part of a paediatric investigation plan.

The aim of the EU Clinical Trials Register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials. The register contains information about clinical trials authorised in the EU, whether they take place in one Member State or several. It includes clinical trials conducted by both industry and research institutions. The information is rendered public once the clinical trial has been authorised.

The register is part of the overarching EU public database EudraPharm, which also centralizes information on medicines authorised by the EU, such as the patient information leaflet. The information is extracted from EudraCT, the EU clinical trials database and is provided by the sponsor of the clinical trial. It is a component of its application to a national medicines regulatory authority for authorisation to conduct a trial.

The information from the sponsor is loaded into the EudraCT database by the national medicines regulatory authority, and 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 European Medicines Agency (EMA), to the system.

Throughout the project the Agency has worked together with stakeholders, including patients and healthcare professionals, to ensure that their needs were taken into account, to the extent possible at this stage, when designing the register. Once this project has been launched, the Agency will continue to work with stakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and completeness of data, and improving the search functionality.

Plans for the future also include the publication of summaries of clinical trial results, on which draft guidance has already been published for consultation by the European Commission. Publication of trial results summaries will require a major upgrade to the existing system, the start of which will depend on finalisation of the guideline and availability of budget and resources.