Posting summary results to the EU Clinical Trials Register
Under the clinical trials Directive 2001/20/EC and the Paediatric Regulation, sponsors in the European Union post the summary results of their interventional trials to the European Clinical Trials Database, and the public reads a subset of them in the EU Clinical Trials Register. The obligation has a start date, deadlines that depend on when a trial ended and on its type, and a set content for what the public sees.
When posting became mandatory
In June 2014 the European Medicines Agency announced that from 21 July 2014 sponsors would be required to post clinical trial results in the European Clinical Trials Database (EudraCT), which the agency manages. That date corresponds to the finalisation of the database's programming, as referred to in a European Commission guideline that applies the clinical trials Directive 2001/20/EC, then in force, and the Paediatric Regulation.
Sponsors were encouraged to start uploading summary results voluntarily when new functionalities were made available in EudraCT in October 2013, so that they could get used to the feature and be ready to comply with the legal requirements. A further iteration of EudraCT with improved functionalities was launched at the beginning of May 2014. The final iteration, due on 21 July 2014, was to put in place all the functionalities sponsors need to post results on a compulsory and systematic basis.
Which trials are covered and by when
EudraCT already held the protocol-related information that sponsors submitted for interventional trials conducted in European Economic Area countries, and for trials conducted in third countries as part of an agreed Paediatric Investigation Plan. That information was already public in the EU Clinical Trials Register. The scope of the information to be posted in EudraCT was also extended to trials that marketing authorisation holders sponsor in third countries and that involve use in the paediatric population of a medicinal product covered by an EU marketing authorisation.
The obligation to post results covers interventional trials registered in EudraCT that ended within a certain period. For any interventional trial that ended on or after 21 July 2014, the sponsor has to post results within 6 or 12 months of the end of the trial, depending on the type of trial. For a trial that ended before that date, the sponsor has to submit the results retrospectively, within the timeframe laid out in the Commission guideline on the posting and publication of result-related information on clinical trials.
Results for paediatric trials within the scope of Article 41 or Article 46 of the Paediatric Regulation, or in an agreed Paediatric Investigation Plan, should be posted to EudraCT within 6 months of the end of the trial, unless this is not possible for objective scientific reasons. Results for non-paediatric trials included in an agreed Paediatric Investigation Plan should be posted within 12 months of the end of the trial.
What the public sees in the register
Under the clinical trials Directive and the Paediatric Regulation, result-related information is fed into the publicly accessible EU Clinical Trials Register, so in June 2014 the agency expected summary results to become available to the public as sponsors started to comply with their legal obligations. A subset of the data in EudraCT is made public in the register. The content and level of detail of the summary results published there are set out in the Commission guideline and its technical guidance. A typical set of summary results gives the objectives of a study, explains how it was designed, and gives its main results and conclusions. Access to summary results was foreseen as an essential feature of the register for interventional trials conducted in European Economic Area countries and for trials conducted in third countries that are linked to European paediatric drug development. By June 2014 a number of summary results could already be viewed on the register's website.
Information on paediatric studies that ended before the Paediatric Regulation came into force in 2007 used to be accessible through the agency's website, and by June 2014 it was available through the register. Holding it in the register allows richer searching and greater public access to trial information.