Since the Clinical Trials Directive’s implementation in 2004, the scientific community has criticised the increase in costs and bureaucratic burden that has resulted, adding that the measures bring no added value to patients.

In response to the first consultation round, launched in October 2009, stakeholders urged the Commission to review the existing provisions. Several draft amendments have been released for consultation, since the original consultation responses were published in March 2010, including measures to improve adverse drug reaction (ADR) reporting, the use of result-related data on the EudraCT database and end of trial notification procedures. The full list of current open consultation amendments can be accessed here.

Since then the Commission launched a further, second round of consultation to clarfiy specific aspects of the directive with stakeholders. This consultation document aksed technical and specific questions concerning the idea of implementing a process called ’Single submission’ with a subsequent ‘coordinated assessment procedure’ as well as trying to clarify the scope of the Clinical Trials directive.

The Directive was designed to improve research standards and protect patients. It changed how medical researchers gain ethical approval for their studies and how new medicines are tested and manufactured. For pharamceutical companies, the effect has been less noticable, as they have been able to add more staff and adapt their procedures. But for those academics and doctors who cannot afford to expand their operations, the outcome in many cases has been cancelled or delayed trials. The second consultation on a revision of the directive questioned whether or not academics should be included within the scope.

The European executive has pledged to adopt legislative solution by mid 2012, but has yet to disclose whether it will simply clarify elements of the existing Directive, or introduce a brand new regulation.

As well as a public consultation to measure the effect of the Directive, the Commission has also (at the end of 2010) produced a "roadmap", outlining its commitment to addressing the Directive’s shortcomings.

The EPHA response to the consultation on the revision of the Clinical Trials Directive was submitted to the European Commission. It focuses on the importance of patient safety within clinical trials, and answers many questions from the consultation concerning emergency trials, trials in third countries and ensuring that trials undertaken have a wide test group including women and older people.


For further information
- European Commission Clinical Trials


Related EPHA articles
- Opportunity to input on recommendations on Clinical Trials Directive, August 2007
- Conference on the Operation of the Clinical Trials Directive, October 2007
- EU Directive on Clinical Trials causes concern
- Clinical Trials: has the EU directive helped to reduce red tape?
- Clinical Trials Register goes live

Last modified on November 16 2011.