Medical Research Safeguarded in Europe

June 16, 2014

LUGANO, Switzerland, June 16, 2014 /PRNewswire/ –

ESMO welcomes the adoption of the Clinical Trials Regulation by the EU

The European Society for Medical Oncology (ESMO) has welcomed the adoption of the
Clinical Trials Regulation
[http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.158.01.0001.01.ENG ]
by the EU, entering into force today.

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 EU 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 will now become law in all Member States, provides a harmonised
framework for conducting clinical trials, focussing on: trial data transparency;
streamlined application process; strict approval timelines; 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.

“The concept of a one-time consent is an essential component of successful medical
research,” said Rolf 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.”

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About ESMO

The European Society for Medical Oncology is the leading European professional
organisation committed to advancing the specialty of medical oncology to advance cancer
care and cure. http://www.esmo.org

        Media contact
        ESMO Press Office

SOURCE European Society for Medical Oncology (ESMO)

Source: PR Newswire

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