Clinical Trials Directive

The Commission plans to review the Clinical Trials Directive and t adopt a new leislative proposal by October 2011.

A pulic consultation on the issue took place until January 2010. A report as well as a summary of the consultation are now available. The ESR has coordinated a response to the European Commission consultation on clinical trials based on an internal survey.

The EU Clinical Trials Directive was implemented in 2004, with the aim of simplifying and harmonising the administrative requirements for clinical trials across the EU, while ensuring

• safety of clinical trial participants
• ethical soundness of trials
• reliability and robustness of data generated.

It is widely accepted that the Directive has improved the safety and ethical soundness of trials across the EU, but a number of issues have emerged which have contributed to making the EU a much less attractive location to carry out clinical trials.

Through the consultation, the European Commission seeked evidence of the strengths and weaknesses of the current legal framework, as well as views on the issues highlighted and ideas on how to address them.

In addition an impact assessment on the application of the Clinical Trials Directive is currently conducted to better assess the application of the clinical trials directive and possible needs for improvement. Based on the findings the Commission will decide whether to simply clarify elements of the existing directive or to propose a new regulation to harmonise research rules across all Member States.

The European Commission hopes to adopt a legislative proposal on clinical trials by October 2011. 

Downloads:

• EC consultation paper
• Clinical Trials Driective (2001/20/EC)
• Final publishable report on the EU project ICREL (Impact on Clinical Research of European Legislation)
• EC Roadmap Document