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European Cancer Organization supports a revision of the EU Clinical Trials Directive
Date:1/26/2010

In response to a European Commission consultation on the EU Clinical Trials Directive, ECCO the European CanCer Organisation has supported proposals by its member organisations for adapting the Directive's requirements to reflect practical necessities in cancer research and treatment.

Since the implementation of the Directive in 2004, ECCO and its member organisations have been concerned about the detrimental effect it has had, particularly on international clinical trials and those that are headed by hospitals, universities, cancer networks and other non-commercial institutions. Lack of harmonisation between European countries in the implementation of the Directive and the increased costs and workload of setting up and running trials has meant that many international trials not aiming at registration of a compound have taken much longer to get started, or, in some cases, have had to be abandoned before start up because of the insurmountable hurdles they faced. At the same time, the Directive does not appear to have improved patient safety in clinical trials or the quality of science.

ECCO's member organisations, including the European Organisation for Research and Treatment of Cancer (EORTC) and the European Society for Paediatric Oncology (SIOP Europe), have responded to the Commission's consultation with a number of proposals for improving the Clinical Trials Directive (2001/20/EC). These include:

Reducing the bureaucracy, workload, and, therefore, the costs, of setting up and running clinical trials by harmonising procedures across all member states, including harmonising and refining the definitions of what is a "clinical trial" and an "investigational medicinal product"; Harmonising the interpretation of rules to avoid confusion over interpretation of "local rules" by competent authorities and Ethic Committees in different countries; Clarifying the role of the clinical trial sponsor (and co-sponsor) the need for a singl
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Contact: Emma Mason
wordmason@mac.com
44-077-112-96986
ECCO-the European CanCer Organisation
Source:Eurekalert

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