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There is consensus between the European Commission, national governments, the pharmaceutical industry, patient groups and both academic and healthcare professional stakeholders that the regulation of clinical trials in Europe is not working to its optimum level, and has not been for many years.
In fact, according to figures provided by the European Commission:
between 2007 and 2010, there has been a 15% decline in both the number of clinical trial studies within EU sites and the number of EU subjects participating in these studies1; and furthermore,
compared with the situation prior to the application of the 2001 Clinical Trials Directive, the staff requirements to handle the trial authorisation process has more than doubled (plus 107%).2
Although other issues are also involved, there is common agreement that a major factor attributed to this decline in trial activity relates to the unintended implementation implications of the EU Clinical Trials Directive (2001/20/EC), including:
differing interpretations of requirements in different member states;
separate definitions of key terms across Europe; and
a lack of guidance in implementing and complying with the Directive.
For these reasons, combined with an economic understanding that Europe's international role in new medicine development could be threatened, modernisation of the Clinical Trials Directive is now taking place.
During 2011, the European Commission led consultation activity to hear initial views and opinions on the main areas for improvement. Subsequently, in July 2012, the Commission published its proposals for change. The proposals will …
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