EMA Specifies Requirements for Transparency of Clinical-Trial Results

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-19-2014 20:02


As of July 21, 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA). This date corresponds to the finalization of the programming of the database as referred to in a European Commission guideline, in application of the current clinical trials Directive 2001/20/EC and the Pediatric Regulation. Under these frameworks, since the result-related information is fed into the publicly accessible European Union Clinical Trials Register, summary results of clinical trials will become available to the public as sponsors start to comply with their legal obligations.

In a statement, EMA explains that sponsors will now be obliged to post results in EudraCT for any interventional trials registered in EudraCT and that have ended within a certain period of time:

  • For any interventional clinical trials that ended on or after 21 July 2014, sponsors will have to post results within six or twelve months following the end of the trial, depending on the type of trial concerned;
  • For trials that ended before that date, sponsors will need to submit the results retrospectively, in accordance with the specific timeframe laid out in the above-mentioned European Commission guideline on the posting and publication of result-related information on clinical trials.

EudraCT already contains protocol-related information submitted by sponsors for interventional clinical trials conducted in European Economic Area (EEA) countries, as well as clinical trials conducted in third countries, when the clinical trial is part of an agreed Pediatric Investigation Plan (PIP). Information on these is already made public in the European Union Clinical Trials Register.

Clinical-trial sponsors were encouraged to start uploading summary results on a voluntary basis, when new functionalities were made available in EudraCT in October 2013. This was intended to enable them to get used to this new feature and be ready to comply with the legal requirements. A further iteration of EudraCT was launched at the beginning of May 2014 with improved functionalities. The scope of the information to be posted in EudraCT has also been extended to include marketing-authorzation holder-sponsored clinical trials conducted in third countries that involve the use in the pediatric population of a medicinal product covered by an EU marketing authorization. As of July 21, 2014,  with the launch of a final iteration of EudraCT, all functionalities will be in place to enable the posting of results by sponsors on a compulsory and systematic basis.

A subset of the data included in EudraCT is made available to the public in the European Union Clinical Trials Register. The content and level of detail of these summary results is set out in the European Commission guideline and in its technical guidance. A number of summary results can already be viewed on the European Union Clinical Trials Register website. A typical set of summary results provides information on the objectives of a given study, explains how it was designed, and gives its main results and conclusions. In addition, information on pediatric studies that ended before the Paediatric Regulation came into force in 2007, which used to be accessible through the EMA website, is now available through the European Union Clinical Trials Register.

Source: EMA


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