Should EU rules for clinical trials be revised?

The European Commission is asking companies and others involved in clinical trials  in Europe to give their views about whether the rules governing these trials should be changed.

Companies wishing to comment on the Commission’s consultation paper (Assessment of the Functioning of the Clinical Trials Directive) may do so by visiting the Commission’s website, http://ec.europa.eu. The deadline for comments is 8 January 2010. The consultation comes at a time when the cost of doing clinical research in the European Union is rising and more and more companies are electing to take their clinical studies to locations outside the region. The migration of clinical studies to third countries reflects the need for companies to be closer to new patient populations, the Commission said.

However there is also evidence that companies are dissatisfied with the way the EU Clinical Trials Directive (Directive 2001/20/EC) has been interpreted by the member states since the legislation came into force in 2004. The Directive sets EU-wide standards for the conduct of trials and spells out how these studies should be authorised and monitored. However, it does not assign responsibility for authorising the start of a trial to a single regulatory authority. Instead, it leaves this job to the individual member states. This means that a company conducting a multinational trial in the EU, where trials are located in two or more member states, needs to get approval for the trial from each of the regulatory authorities in the territory where the trial will take place. As a result, trials do not get started promptly, and they can be very costly. This is a particular burden for small companies.

In addition, the Directive requires that companies report all suspected unexpected serious adverse reactions (SUSARs) relating to drugs used in trials to a central database. However, the member states have different interpretations of what constitutes a SUSAR. As a result, companies appear to be providing too much information to the database and there has been a six-fold increase in the number of reports since the Directive took effect.

The Commission is asking stakeholders to comment on whether the Directive should be amended, or whether it should be replaced by a Regulation which would be implemented directly from Brussels without the intervention of national parliaments. It is also asking whether the clinical trial approval process should be centralised, by either having a single authority issue approvals, or by having the national regulators mutually recognise an approval issued by one member state.

The chart which appears on the Home Page of this website summarises data from the European Clinical Trials Database or EudraCT. The figures for 2009 are complete up to 30 September. The chart, and other information about the Commission’s consultation, can be found in the document, Assessment of the Functioning of the Clinical Trials Directive at http://ec.europa.eu.

Copyright 2009 Evernow Publishing Ltd

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