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EU Clinical Trials Regulation


The EU Clinical Trials Regulation can facilitate and harmonise how clinical trials and medical research are performed across Europe

ESMO welcomed the adoption of the EU Clinical Trials Regulation by the Council of the European Union and the European Parliament in 2014. Following an independent audit of the supporting IT infrastructure (EU portal and database), the Regulation entered into application on 31 January 2022. It replaced the 2001 EU Clinical Trials Directive.

The EU Clinical Trials Regulation aims to create a more favourable environment for research in Europe, as well as maintain the highest level of standards for patient safety, and increased transparency of clinical trial information. The Regulation acknowledges the importance of being able to use data beyond the end of a clinical trial for research purposes. Its effectiveness will depend on its appropriate implementation at the national level.

In 2015, ESMO, together with the European Organization for Research and Treatment of Cancer (EORTC), published a position paper with an overview of the achievements, challenges, and solutions related to the EU Clinical Trials Regulation and the European Medicines Agency’s (EMA) Transparency Policy.

Main points of the EU 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. It is essential that this concept is implemented consistently within both the EU Clinical Trials Regulation and the EU General Data Protection Regulation, and also in all countries because some regulations, like ethical approval, will be the competence of individual national authorities.
  • 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 (while maintaining the role of ethical committees)
  • Definition of ultra-rare diseases as a political concept introduced for the first time at EU level

ESMO is working to ensure that medical oncologists are well informed about the implications of the new Regulation. Together with EU Cooperative Research Groups, and the Clinical Academic Cancer Research Form (CAREFOR), ESMO will monitor the implementation of the EU Clinical Trials Regulation and provide constructive input and feedback to the relevant bodies responsible for the harmonisation of its implementation across the European Union.  

CAREFOR is a collaborative effort between ESMO, EORTC and EACR.

In 2017, CAREFOR published a position paper on Safeguarding the Future of Independent, Academic Clinical Cancer Research in Europe for the Benefit of Patients. The paper outlines CAREFOR’s scope and goals to protect and promote academic clinical cancer research in Europe.

In 2020, CAREFOR published a paper in 2020 on Current models, challenges and best practices for work conducted between European academic cooperative groups and industry outlining how academic research groups should interact with the industry.

ESMO continues to be engaged in policy efforts to facilitate cancer research in Europe to support its members and improve patient outcomes.

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