Medical Research Safeguarded in Europe - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
Medical Research Safeguarded in Europe


Medical Research Safeguarded in Europe

PR Newswire

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 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."

Full story: http://www.esmo.org/Press-Office/Press-Releases/Medical-research-safeguarded-in-Europe

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
media@esmo.org
+41(0)91-973-19-07

SOURCE European Society for Medical Oncology (ESMO)

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
86%
Borrow lightly from EMA's pathway program?
7%
Create entirely its own pathway program?
7%
View Results
Untitled Document

Click here