Changes recommended for EU Clinical Trials Directive
Written by Andres Heuberger on Thursday, March 11, 2010
There may be some big changes afoot for the European Union's Clinical Trials Directive (2001/20/EC).
Pretty much ever since it became law in 2004, various sponsors, industry groups, and advocacy groups have called for changes and improvements to the directive. The European Cancer Organization (ECCO) is one of the latest to call for changes to the directive.
ECCO supports an effort to streamline trials and has voiced this to the European Commission. Currently, there is a lack of harmonization among European countries with respect to conducting clinical trials. This has led to confusion, red tape,and delays in trials - and thus delays in getting therapies to patients.
Some of the changes proposed include clarifying the role of the sponsor, centralizing the Clinical Trial Authorisation, simplifying the process for amendments, and reducing bureaucracy. ECCO's press release has all of the details.
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