Lugano, Switzerland - The European Society for Medical Oncology (ESMO), the leading pan-European association representing medical oncology professionals, has welcomed the adoption of the Clinical Trials Regulation [1] by the Council of the European Union and the European Parliament, which enters into force this week.
The new clinical trial framework acknowledges the importance of using data stored for a clinical trial beyond the end of the study itself, for research purposes. Practically speaking, the Regulation states that when a patient gives his/her consent for a clinical trial, he/she can easily give a one-time consent for data to be used beyond the trial, for the purpose of medical research, still with the possibility to withdraw it at any time [2].
“The adoption of the Clinical Trials Regulation by the EU represents an important milestone according to ESMO, in support of our efforts to safeguard medical research in Europe,” said Paolo G. Casali, ESMO Public Policy Committee Chair. “ESMO is keen on protecting and furthering medical research in Europe, and the EU has given a clear signal that they support medical research, including oncology research and care, whilst fully respecting the right of the patient to privacy and confidentiality.”
The Regulation, which will now become law in all 28 EU Member States, provides a harmonised framework for conducting clinical trials: it introduces strong transparency of clinical trial data through the publication of all studies into a single website. Furthermore, whilst maintaining the central role of ethical committees, it streamlines the application process, adding strict timelines for approval by Member States, and creating a single portal that reduces the bureaucratic burden on researchers, particularly for multi-country clinical trials.
“The lengthy procedure of starting a clinical trial until the inclusion of the first patient has been known to the scientific community for a long time,” said Christoph Zielinski, ESMO Board member responsible for relations with cooperative research groups. The magnitude of the problem has increased when international cooperative groups have introduced large clinical trials across European countries where regulations are different, leading to non-uniform trial execution. “The new Regulation should facilitate the performance of clinical trials in Europe, synchronising national regulations into a supranational strategy.”
“The novel Clinical Trials Regulation represents Europe’s unique chance of overcoming the old directive to make Europe competitive, attractive and visionary in conducting the fundamental clinical trials necessary for our fight against cancer,” said Christian Dittrich, Coordinator of the ESMO Faculty for Principles of Clinical Trials and Systemic Therapy. “It is equipped to ensure that medical research will be able to continue in a smooth manner, for the ultimate benefit of patients.”
“The new Regulation includes many topics that patients have been advocating for,” said Jan Geissler, Chronic Myeloid Leukaemia Advocates Network. “Patients need more progress in research to develop new, effective and safe therapies at a faster pace, and with the new Regulation European cancer research will become more patient-centric.”
“The concept of a one-time consent is an essential component of successful medical research” said Rolf A. Stahel, ESMO President. “Its inclusion in the new Clinical Trials Regulation is a welcomed recognition of its importance for the medical community at large, like other crucial aspects that ESMO is relentlessly acting on to secure a trouble-free research environment for medical oncology in Europe.”
ESMO collaborates closely with many European organisations, in a constant effort to support medical oncology. For the new Clinical Trials Regulation, EORTC has been at the frontline of a collective effort with ESMO, allowing us to continue to represent our members on key issues in our role as the leading medical oncology society in Europe.
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Notes to Editors
References
[2] Article 28 point 2 and Recital 29 of the Regulation