The EU Clinical Trials Directive (Directive 2001/20/EC) was implemented in 2004, with the aim of simplifying and harmonising the administrative requirements for clinical trials across the EU, whilst ensuring the safety of clinical trial participants, the ethical soundness of trials and the reliability and robustness of data generated.

*LATEST NEWS*

Draft guidance on the collection, verification and presentation of adverse reports arising from clinical trials on medicinal products for human use  

The European Commission has published a draft revision of the existing guidance on adverse reaction reporting, including SUSAR reporting. This initiative is in response to calls from stakeholders to clarify this area during the public consultation on the functioning of the Clinical Trials Directive, mentioned below.

The NHS European Office will be responding to the consultation on behalf of NHS organisations.

Please contact Sally.Elkes@nhsconfed.org if you have any queries.

Reviewing the EU Clinical Trials Directive

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

The European Commission launched a consultation late last year, which sought detailed input on how the Directive is working, and looked at various options for remedying shortcomings and unintended consequences that have become apparent since the implementation of the Directive. Through the consultation, the European Commission sought 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.

The consultation considered a number of specific issues, including:

• Measures to streamline procedures for multinational trials
• Mechanisms to address weaknesses with regards the reporting of serious adverse events
• How to develop a more risk-based approach to clinical trials

Many of the issues covered in the consultation were of interest to NHS organisations and their partners involved in medical research and innovation in healthcare, and our briefing explored some of these in more detail.

Responses to the consultation

The NHS European Office coordinated a response to the consultation based on input from NHS organisations and also liaised with other interested UK and EU stakeholders who were responding to the consultation. The European Commission has prepared a summary of the responses which suggests that, whilst many of the concerns about how the framework is currently functioning are shared, there is no clear consensus on how problem areas are best addressed.

Next steps

These consultations are part of a wider impact assessment exercise, which is ongoing and is expected to be completed during 2010/11. The NHS European Office will continue to monitor this work and will keep NHS organisations informed of future developments.

For more information please contact: Sally.Elkes@nhsconfed.org.