EU Clincal Trials Regulation: General Information

The Regulation acknowledges the importance of clinical trial data to be used after a trial for research purposes

ESMO welcomes the adoption of the Clinical Trials Regulation by the Council of the European Union and the European Parliament. The Regulation, which will become law in all 28 EU Member States, acknowledges the importance of data stored for a clinical trial to be used beyond the end of a clinical trial, for research purposes, and ensures that medical research will be able to continue in a smooth manner.

Main points of the Clinical Trials Regulation:

  • Introduction of the concept of a patient’s ‘one-time’ consent for use of data, tissues and biological samples, exclusively for the purposes of medical research, that extends beyond the trial itself, with the possibility for the patient to withdraw consent at any time. This concept of ‘one-time’ consent needs to be included also in the EU General Data Protection Regulation to assure both Regulations have a coherent position on the topic.
  • Strong transparency of clinical trial data through the publication of all studies, regardless of results, on a single website
  • Streamlining of the application process, adding strict timelines for approval by Member States
  • Creation of a single portal for data submissions that will reduce the bureaucratic burden on researchers, particularly for multi-country clinical trials
  • Creation of an EU database identifying each clinical trial
  • Opinions will now have to be issued within new legally provided timelines (whilst maintaining the role of ethical committees)
  • Definition of ultra-rare diseases as a political concept introduced for the first time at EU level

Next steps

The text will enter into force once published in the Official Journal of the European Union and will apply six months after the single portal and database, to be created by the European Medicines Agency (EMA), have become fully functional (but not earlier than two years after the regulation's publication).