Paediatric clinical trials
The European Medicines Agency (EMA) makes information on clinical trials in children (and in adults) available via a public interface, the European Union Clinical Trials Register (EU CTR) since March 2011. The EU CTR is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the European Economic Area (EEA).
EudraCT contains information on all trials performed anywhere in the world with children, if the trial:
- is part of an agreed paediatric investigation plan (PIP), or;
- is sponsored by a marketing-authorisation holder and involves the paediatric use of a medicine that has a European Union (EU) marketing authorisation.
The information published through the EU CTR includes the main elements of the trial protocol and a summary of the trial results once the trial has been completed. This also applies to trials terminated prematurely.
EudraCT is managed by EMA.
Information on older paediatric clinical trials
The Agency publishes information on older paediatric clinical trials which were completed before 2007 and carried out with medicines with an EU marketing authorisation. This is in line with Article 45 of the Paediatric Regulation. Information on these trials is available through the EU Clinical Trials Register.
The Agency publishes these data after the marketing-authorisation holder has submitted it to the Agency for assessment. For more information, see Submitting results of paediatric studies.
Guidance on posting and publication of trial information
Result-related information for interventional clinical trials in children and/or adults included in an agreed PIP has to be posted directly to the EudraCT database using the full EudraCT data set. If protocol-related information is not already registered in EudraCT, for instance, if the trial is conducted outside the EU, prior upload of protocol-related information to EudraCT is legally required.
In order to post this information, users need to be registered with EudraCT. To post information on clinical trials conducted in countries outside the EU, PIP addressees or marketing-authorisation holders will need to be registered as a 'third-country data provider'. For more information, see EudraCT user roles.
The European Commission has published guidance on the information concerning paediatric clinical trials to be entered into EudraCT and on the information to be made public by the Agency. It includes the list of fields to be made public from EudraCT from paediatric trials, and guidance relating to the posting and publication of result-related information. For full details, see EudraLex - Volume 10 Clinical trials guidelines.
For information on posting study results for publications in line with Articles 45 and 46 of the Paediatric Regulation, see Submitting results of paediatric studies.
Full details on how to post information is available on EudraCT frequently asked questions.