The new framework acknowledges the importance of using data stored for a clinical trial beyond the end of the study itself, for research purposes. Practically speaking, when a patient gives consent for a clinical trial, he/she can easily give a one-time consent for data to be used beyond the trial, for medical research purposes, still with the possibility to withdraw it at any time.
"The adoption by the E.U. represents an important milestone, according to ESMO, in support of our efforts to safeguard medical research in Europe," said Paolo Casali, ESMO public policy committee chair.
The regulation, which now will become law in all member states, provides a harmonized framework for conducting clinical trials, focusing on trial data transparency, streamlined application process, strict approval timelines and reduced bureaucracy for multi-country studies.
"The novel Clinical Trials Regulation represents Europe's unique chance to make Europe competitive, attractive and visionary in conducting the fundamental trials necessary for our fight against cancer," said Christian Dittrich, ESMO faculty coordinator. "It is equipped to ensure that medical research will be able to continue in a smooth manner, for the ultimate benefit of patients."
"Patients need more progress in research to develop new, effective and safe therapies at a faster pace; with the new regulation, European cancer research will become more patient-centric," said Jan Geissler, CML Advocates Network.
