Change is in the air for the European Clinical Trials Directive - Pharmaceutical Technology

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Change is in the air for the European Clinical Trials Directive
Though many advantages are associated with the European Clinical Trials Directive, complexities have emerged since its introduction in 2004. Since 2007, efforts have been made to raise the issues and address the negative impact of the Directive, and the European Commission is currently assessing stakeholder feedback from a public consultation document, which could lead to changes for the European Clinical Trials Directive.

Pharmaceutical Technology Europe
Volume 22, Issue 5

Encouraging further improvement

Since 2007, there have been further efforts to address the negative impact of the Clinical Trials Directive. In 2008, the EC launched a study entitled Impact on Clinical Research of European Legislation (ICREL). ICREL was a longitudinal, retrospective, observational and comparative study to assess the impact of the Clinical Trial Directive, for the period 2004 to 2007, by examining the number, size and nature of clinical trials, and assessing workload, resourcing, costs and performance.4,5 ICREL concluded that overall there had been no reduction in clinical trial activity in the EU. However, it did show that conducting clinical trials in the EU had become more costly and burdensome, thereby validating concerns raised by participants at the 2007 EC-EMEA conference.

ICREL found that, while harmonisation focused on quality standards for clinical trials in different member states, there appeared to have been no effort to standardise ethics committee systems and approval procedures in the different countries.5 Safety data reporting was also handled differently by the different member states, causing additional administrative burden. For example, different member states have different interpretations of what constitutes a suspected unexpected serious adverse reaction (SUSAR) and this has caused an information overflow for the EU central database.6 There has been a sixfold increase in the number of safety data reports lodged since the Clinical Trials Directive took effect, as sponsors attempt to make sure they are complying with safety requirements.6

The benefit of ICREL was that it provided metrics for the issues that were considered to be damaging the European clinical research environment. The data should be useful when it comes to discussions about how to best revise European clinical trial legislation. At the end of 2009, the EC sent out a public consultation document and asked stakeholders whether the rules for European clinical trials should be changed.6 The deadline for comments was 8 January 2010.

It will be interesting to see how the EC follows up on feedback received and how it uses the ICREL data. For example, the ICREL results favoured a simplification of the Clinical Trial Authorisation (CTA) process through a single CTA for multinational trials by showing that it could reduce duplication of effort and also save time and cost.5 The authors of the ICREL report have suggested that the study be repeated at regular intervals to monitor the impact of EU legislation on the clinical trials environment. Furthermore, they suggest a comparison with the clinical trials environment in nonEU regions, such as the US, Canada and Japan.5 International analyses of this nature could also be valuable in ongoing efforts to make the EU more competitive for pharmaceutical R&D.

The author says...

• The European Clinical Trials Directive was introduced in 2004, but the complexities of developing a pan-European system to the satisfaction of multiple parties and member states led to delays in implementing the Directive in many countries.

• Companies operating in Europe as well as academic institutes found the new processes unclear.

• Pressure from disgruntled researchers and companies led to a meeting in 2007, held by the EC and European Medicines Agency, to examine the status of clinical development in Europe and the Clinical Trials Directive in practice.

• Since 2007, efforts have been made to address the negative impact of the Directive — the EC is currently reviewing feedback from a public consultation document, as well as data from its own research, to assess whether changes need to be made to the Directive.

Faiz Kermani is a freelance consultant and President of the Global Health Education Foundation, a charity that supports medical education and research projects in developing countries. He is a member of Pharmaceutical Technology Europe's Editorial Advisory Board.


1. F. Kermani and C. Narayan, Nature Biotech (February 2005).

2. Pharmaceutical-int International, "The EU Clinical Trials Directive — One Year On" (2005).

3. A. Hemminki and P-L. Kellokumpu-Lehtinen, BMJ , 332, 501–502 (2006).

4. European Medicines Agency, "European Commission-European Medicines Agency Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future. Report on the European Commission–European Medicines Agency clinical trials conference" (2007).

5. European Commission, "Assessment of the functioning of the "Clinical Trials Directive" 2001/20/EC. Public consultation paper" (2009).

6. MedNous, "Should EU rules for clinical trials be revised?" (2009).


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