Intended for healthcare professionals


Has the European Clinical Trials Directive been a success?

BMJ 2010; 340 doi: (Published 09 April 2010) Cite this as: BMJ 2010;340:c1862
  1. L J Frewer, chair of food safety and consumer behaviour1,
  2. D Coles, research associate2,
  3. K Champion, clinical trials director3,
  4. J Demotes-Mainard, project coordinator, ECRIN4,
  5. N Goetbuget, head of study centre and project leader 5,
  6. K Ihrig, scientific coordinator5,
  7. I Klingmann, chairman, EFCGP6,
  8. C Kubiak, executive manager, ECRIN 4,
  9. S A Lejeune, European Union programme officer, EORTC7,
  10. F McDonald, executive officer, EBMT3,
  11. J Apperley, chair of haematology8
  1. 1University of Wageningen, 6701 BH Wageningen, Netherlands
  2. 2University of Central Lancashire, Preston PR1 2TQ
  3. 3European Group for Blood and Marrow Transplantation, 08036 Barcelona, Spain
  4. 4INSERM, 75013 Paris, France
  5. 5Information Center of European Leukemia Net, Goethe University, 60590 Frankfurt, Germany
  6. 6Pharmaplex bvba, 1970 Wezembeek-Oppem, Belgium
  7. 7EORTC, Brussels 1200, Belgium
  8. 8Department of Haematology, Imperial College, London W12 0NN
  1. j.apperley{at}

    The academic community expresses concerns about its implementation

    The laudable aims of the European Clinical Trials Directive (EU 2001/20/EC) were to improve the safety and efficiency of both commercial and investigator driven clinical trials and to provide the basis for improved European competitiveness. Unfortunately, even before the directive was finalised, concerns were voiced about potential adverse effects on studies designed to test and implement scientific discoveries in clinical practice (translational research) in Europe.1 2 Today, five years after implementation, evidence shows that the directive has had a negative effect on translational research.

    The directive was designed to optimise patient safety, increase the numbers of patients entered into clinical trials, improve the efficiency of trial implementation, ensure best practice in ethical review and regulatory procedures, and harmonise these procedures across Europe. In fact, the implementation of the directive by individual EU member states has caused legislative differences between the different nations and obstacles to the conduct of clinical trials.3 Although practice has improved in some areas of Europe,4 in general the regulatory requirements are highly demanding and expensive, irrespective of the level …

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