***Update 23 March 2011***

The online registry of clinical trials giving the public access to information on clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway is now ’live’. The public can also search the database for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.

The following information about how information reaches the stage where it is available to the public comes from the European Medicines Agency: ’The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. It is provided by the sponsor of the clinical trial, and 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. 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 EMA, to the system.’

The publication of the clinical trials registry increases transparency in medicines research and represents s a positive step for patients wishing to access information about clinical trials in Europe.

The European Institute of Women’s Health also welcomed this move towards greater transparency of clinical trials. “It is an important step for good science for men and women”, said Hildrun Sundseth, EIWH Board Member who sits on the EMA working group. “In the past women could not always be sure that they were included in clinical trials in appropriate numbers to test the medicine. Now the evidence should become clearer and reassure female patients. “ Her colleague Peggy Maguire, Director General EIWH commented: “We are pleased that this new EU Clinical Trial Register will make more scientific information available to the general public. Patients and their carers can now find evidence-based information posted on the EMA website. The Register is a start towards greater transparency ; and we will continue our work with EMA to improve the quality and completeness of the data to serve patients needs and - importantly - to take account of gender-based differences.”

For more information: Peggy Maguire - Director General EIWH - peg@euroheath.ie Hildrun Sundseth, Board Member EIWH - hildrun.sundseth@eurohealth.ie

Related EPHA Articles

- European Commission revamping clinical trials directive - EPHA responds

**Update 16 June 2009** The EMEA is currently carrying out a survey to better understand which aspects of clinical trial information are of most interest, how people might use this information and how they will want to access it. This research will help the EMEA to design a website appropriate for the needs of the public and other interested parties.

The survey is available here.

The EudraCT database, a database of all clinical trials in Europe is hosted and run by the European Medicines Agency (EMEA). In its current form, the data is only available to competent authorities (Member State authorities responsible for authorising clinical trials in their territory) as the aim of the database is to increase data sharing and coordination between Member States. However, new legislation means that in the latest update of EudraCT, the information will be made publicly available.

The current EudraCT database is Version 6 but a newer updated version, Version 7, will go online in June 2009. The updated version of EudraCT, will have three new functionalities which will attempt to make the life of the sponsors (those companies or research facilities sponsoring the clinical trial) easier.

However the version of the database that constitutes the biggest breakthrough to citizens will be Version 8 which is now in production and will go online in November 2009. Version 8 will build on Version 7 to introduce more clinical trial data from third country trials and perhaps the most important new functionality: making this data available to the public.

The public part of the database will be available online and will bring all data on clinical trials happening in Europe together in one place. It will include trials of products that do not have marketing authorisation and includes third country trials that form part of a Paediatric Investigation Plan (PIP) (a PIP is a way of collating all data relating to trials on children and ensuring that the reformulation of the products for children is documented)

Clinical Trials with a decision of the Competent Authority and/or an opinion of the Ethics Committee will be made public, automatically, as soon as this information is recorded in EudraCT.

Version 9 will be available in September/October 2010. Where the EudraCT database has so far included information on the application for clinical trials, version 9 will include more functions based around the publication of the results of clinical trials.

What is the EudraCT Database?

The Eudra CT database is a database of all clinical trials in Europe established on 1 May 2004 under Directive 2001/20/EC article 11, that governs the rules for clinical trials in the EU. The initial purpose of the database was to enable sharing of data between competent authorities responsible for approving and monitoring clinical trials happening on their territories. Later legislation provided a derogation to make the database more transparent and open to the public. Initially all clinical trials that were applied for in the EU had to go into the database, however this was widened to include clinical paediatric trials from third countries as well.

Currently there are 19,219 distinct clinical intervention trials of medicinal products with one investigator site in the EU in the database.

For more information

- Please visit the EudraCT website
- Please visit the EMEA website

EPHA related articles

- New recommendations on ethical aspects of clinical trials in children
- Conference on the Operation of the Clinical Trials Directive, October 2007
- Patients want and need results of clinical trials
- Clinical Trials: has the EU directive helped to reduce red tape?

Last modified on May 20 2011.