EU Clinical Trials Register
EU Clinical Trials Register：https://www.clinicaltrialsregister.eu
About the EU Clinical Trials Register
The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.
Clinical trials conducted outside the EU/EEA are included if:
they form part of a paediatric investigation plan (PIP), or:
they are sponsored by a marketing authorisation holder, and involve the use of a medicine in the paediatric population as part of an EU marketing authorisation.
The Register also provides information about older paediatric trials covered by an EU marketing authorisation.
The Register enables you to search for information in the EudraCT database External link. This is the database used by national medicines regulators for data related to clinical trial protocols. The data on the results of these trials are entered into the database by the sponsors themselves and are published in this Register once the sponsors have validated the data.
The EU clinical trials register has been a primary registry in the World Health Organization (WHO's) Registry Network since September 2011 and is a WHO Registry Network data provider. It is also available on the WHO International Clinical Trials Registry Platform External link.
In this Register, you are able to:
view the description of phase II to phase IV adult clinical trials where the investigator sites are in the EU/EEA;
view the description of any paediatric clinical trial with investigator sites in the EU/EEA;
view the description of any paediatric clinical trial that is sponsored by a marketing authorisation holder and involves the use of a medicinal product covered by an EU marketing authorisation in the paediatric population including trials conducted outside the EU / EEA;
view the description of any trials which form part of an agreed paediatric investigation plan (PIP) including those where the investigator sites are outside the EU/EEA;
view the summary results of the the clinical trials mentioned above;
view the summary results (with a reduced set of data fields) of paediatric trials completed by 26 January 2007 covered by an EU marketing authorisation;
download up to 20 results (per request) in a text file (.txt).
The details in the protocol related information include:
the design of the trial;
the sponsor;
the investigational medicine (trade name or active substance);
the therapeutic areas;
the status (authorised, ongoing or complete).
The details of the information of the summary results for a trial include:
the summary results in the form of datasets including:
trial information;
subject disposition;
baseline characteristics;
endpoints;
adverse events;
additional information;
summary attachment(s).
What is not available?
The EU Clinical Trials Register does not:
provide information on non-interventional clinical trials of medicines (observational studies on authorised medicines);
provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures;
provide access to authorisation documents from national medicines regulators or the opinion documents from ethics committees;
provide information on clinical trials where all of the investigator sites are outside of the EU/EEA, except for trials that formed part of an agreed (PIP);
manage the process for joining a clinical trial published on the website;
provide navigation and web content in languages other than English.
Legal basis
The EU Clinical Trials Register website was launched to provide the public with information held in the EudraCT database, the application that is used by national competent authorities to enter clinical trial data. The EudraCT database was established in Article 11 of the Clinical Trial Directive 2001/20/EC PDF document [152kB]. Since then changes to the EU pharmaceutical legislation (Article 57 of Regulation (EC) No 726/2004 PDF document [207kB] and Article 41 of the Paediatric Regulation (EC) No 1901/2006 PDF document [203kB]) allow some of the information held in the EudraCT database is to be made public.
Information on paediatric clinical trials completed by 26 January 2007, in respect of products authorised in the EU / EEA, is submitted by pharmaceutical companies in accordance with Article 45 of the Paediatric Regulation (EC) No 1901/2006. Paediatric clinical trials that are marketing-authorisation-holder-sponsored and involve the use of a medicinal product covered by an EU marketing authorisation in the paediatric population are included in the Register in accordance with Article 46 of Regulation (EC) No 1901/2006
Source of information
The information that appears on the EU Clinical Trials Register is originally provided by the company or organisation responsible for the clinical trial. The protocol related information is a component of the sponsor application to a national competent authority for authorisation to conduct a trial. The information is loaded into the EudraCT database by the national competent authority. The national competent authority adds to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. The protocol related information on clinical trials that are conducted outside of the European Union and the European Economic Area is supplied by the company or organisation responsible.
The results related information on clinical trials conducted in the EEA or outside of the EEA is shown as posted into EudraCT by the sponsor/marketing authorisation holder or (PIP) addressee.
The European Medicines Agency (EMA) is not responsible for the completeness or accuracy of this information. In addition, the EMA and national competent authorities assume no liability for any party's use, or the results of such use, of any part of the database.
Clinical trials in the European Union
The European Clinical Trials Directive 2001/20/EC PDF document [152kB] was introduced to protect clinical trial participants and to harmonise the supervision of clinical trials in the European Union. The European Union Clinical Trials Directive 2001/20/EC provides a framework which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. Member States have transposed the requirements of the directive into national laws, regulations and administrative provisions. The approval of clinical trial applications is the responsibility of the member states. Find out more on clinical trials in the European Union External website(European Commission website) and information on national medicine regulatory authorities External website on this website.
