Archive for the ‘Clinical trials registry’ Tag

The EU Register of Clinical Trials is launched Online.

On 22 March the EU register of clinical trails has been launched online
The aim is more transparency for patients and avoidance of unnecessary duplication of clinical trials

Clinical trials performed in the EU must be conducted by the EU Clinical Trials Directive (2001/20/EC) and implementing legislation. This legislation lays down principles and detailed guidelines for good clinical practice for investigating medicinal products for human use. It aims at ensuring a high level of protection of patient safety, as well as reliability and robustness of the data generated in a trial. To this end, the legislation and implementing guidance specify various aspects of clinical trials including:

* Information that must be submitted to the competent authorities and to the ethics committees
* Requirements for ‘informed consent’ of the clinical trial participants
* Requirements on safety monitoring and the reporting of adverse reactions
* Requirements on Good Clinical Practice, including the documentation, of the clinical trials
* Specific requirements on the products tested, including manufacturing and labelling
* The inspections of competent authorities and applicable procedures.

The Clinical Trials register has information about clinical trials authorised in the EU, whether they take place in one Member State or in 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 also includes the clinical trials contained in a Paediatric Investigation Plan – the research and development program that aims to generate the data required to authorise a medicinal product for use in children. The clinical trials contained in such a Plan are published even if they are performed outside the EU.

The clinical trials register:
http://www.ClinicalTrialsRegister.eu

Further information:
http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm

Source: press release of RAPEX 22 March: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/339&format=HTML&aged=0&language=en&guiLanguage=en