The European Commission has laid down parameters for information in the EU’s clinical trial database, EudraCT, that could be made publicly accessible through EudraPharm, the database on medicines approved in the European Union.

Launched to the general public in December 2006, the EudraPharm database was set up under Article 57 of the EU’s Regulation (EC) No. 726/2004. Article 57 also stipulates that, where appropriate, the EudraPharm database should include references to data on clinical trials held in EudraCT. At the moment, the EudraCT database is only accessible to the European Medicines Agency (EMEA) and the competent authorities of the EU member states.

As a result, the Commission has issued a guideline on the trials and data fields in EudraCT that would be suitable for inclusion in EudraPharm, as well as criteria for updating these data. “The overall purpose is to provide relevant information to the public in the interests of public health,” it stated.

Making information about ongoing or completed clinical trials more widely available is not only of potential value to patients, their carers and the health professions but can also “contribute to the development of further research helping to ensure that better trials are designed, requiring fewer patients and avoiding unnecessary duplication”, the Commission noted.

The EudraCT database includes information on clinical trials with at least one site in the EU, and which began in at least one member state following the transposition of Directive 2001/20/EC. As things stand, its data fields are mostly consistent with initiatives on clinical trial registries taken by international bodies such as the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE), the Commission pointed out.

According to the guideline, the elements to be included in EudraPharm maintain a balance between the current restricted access to EudraCT – “in order to ensure that the confidentiality of the data is strictly observed and to protect the legitimate interests of sponsors” – and the need to inform the general public in the interests of public health and transparency. As such, these elements must be “meaningful for the public, also by following agreed standards at international level”.

They will include information on Phase II, III and IV clinical trials, regardless of whether or not the drug concerned has already received a marketing authorisation in the EU. Left out of the equation will be Phase I trials, “certain details” of the characterisation of investigational medicinal products and of clinical trial designs, information on batch releases, the legal status of the sponsor, clinical trial sites and any related personal information.

More comprehensive details on the clinical trial data to be included in EudraPharm will be published by the Commission’s Enterprise and Industry directorate. The guideline on data fields for inclusion in EudraPharm can be found online at http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2008_07/c_16820080703en00030004.pdf.