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Project Final Report PROJECT FINAL REPORT Publishable Grant Agreement number: HEALTH-F1-2007-201002 Project acronym: ICREL Project title: IMPACT ON CLINICAL RESEARCH OF EUROPEAN LEGISLATION Funding Scheme: CSA COORDINATION AND SUPPORT ACTION – SA SUPPORTING ACTION Period covered: from 01 January 2008 to 31 December 2008 Project co-ordinator name, Title and Organisation: Dr. Ingrid Klingmann, Project Coordinator, EFGCP Tel: +32 2 784 36 93 Fax: +32 2 784 30 66 E-mail: [email protected] Project website address: www.efgp.be/ICREL 1 ICREL – FINAL REPORT PUBLISHABLE – FEBRUARY 2009 Impact on Clinical Research of European Legislation (ICREL) Final Report – First Version 09 February 2009 European Commission, Directorate Research Grant Agreement Number: HEALTH‐F1‐2007‐201002 Submitted by the European Forum for Good Clinical Practice (EFGCP) in collaboration with European Clinical Research Infrastructures Network (ECRIN) European Organisation for Research and Treatment of Cancer (EORTC) Ethics Committee, Medical University of Vienna Hospital Clinic I Provincial de Barcelona Contact: Dr. Ingrid Klingmann European Forum for Good Clinical Practice Rue de l’Industrie 4 1000 Brussels Belgium Tel: +32 2 732 87 83 E‐mail: [email protected] - 2 - Table of Contents The Consortium....................................................................................................................................7 Executive Summary .............................................................................................................................8 Introduction and Rationale...............................................................................................................8 Methodology ....................................................................................................................................9 Results..............................................................................................................................................9 Competent Authorities .....................................................................................................................9 Ethics Committees .........................................................................................................................10 Commercial Sponsors ....................................................................................................................11 Non-Commercial Sponsors............................................................................................................11 Overall Conclusion and Recommendation ....................................................................................12 Abbreviations.....................................................................................................................................13 Glossary .............................................................................................................................................15 Introduction........................................................................................................................................20 Historical context ...........................................................................................................................20 Development of national legislation ..............................................................................................20 The EU Clinical Trials Directive (CTD)........................................................................................21 Rationale ............................................................................................................................................24 Objectives...........................................................................................................................................24 Review of other assessments, reports, analyses and case studies ......................................................25 Multi-stakeholder-related...............................................................................................................25 International aspects...................................................................................................................25 Is the randomized controlled drug trial in Europe lagging behind the USA?........................25 Trends in the globalization of clinical trials ..........................................................................26 Pan-European aspects ................................................................................................................26 Vienna Initiative to Save European Academic Research (VISEAR) ....................................26 Clinical research in Europe: national differences in legislative and regulatory frameworks 27 Who’s afraid of the European Clinical Trials Directive? ......................................................29 Outcome of the Clinical Trials Directive on clinical cancer research in Europe: a 3-years’-follow-up analysis....................................................................................................30 Does the European Clinical Trials Directive really improve clinical trial approval time?....30 The Clinical Trials Directive: 3 years on...............................................................................31 Data from the EudraCT database...........................................................................................31 National Aspects: Denmark .......................................................................................................31 Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.................31 Competent Authority-related .........................................................................................................32 National Aspects: Germany .......................................................................................................32 CTA applications at BfArM and PEI.....................................................................................32 National Aspects: Italy...............................................................................................................33 Bulletin Clinical Trials of Drugs in Italy ...............................................................................33 Ethics Committee-related...............................................................................................................34 Pan-European aspects ................................................................................................................34 The Procedure for the Ethical Review of Protocols for Clinical research Projects in the European Union .....................................................................................................................34 National Aspects: The Netherlands............................................................................................35 Nefarma Clinical Trial Database (NCTD) Monitor...............................................................35 - 3 - Commercial sponsor-related ..........................................................................................................35 Pan-European aspects ................................................................................................................35 Promoting Consistency of Implementation and Interpretation of the Clinical Trials Directive across EU Member States ......................................................................................35 Results of the Joint EFPIA-PhARMA Survey on the Implementation of the Clinical Trial Directive in Europe ................................................................................................................37 National Aspects: France ...........................................................................................................38 France, an attractive country for international clinical research: 2008 survey ......................38 National Aspects: Germany .......................................................................................................38 Genehmigung klinischer Prüfungen in Deutschland .............................................................38 Non-commercial sponsor-related...................................................................................................39 International aspects...................................................................................................................39 Investigator Initiated Clinical Trials Characteristics .............................................................39 Pan-European aspects ................................................................................................................39 FECS survey on the impact of the directive on academic research.......................................39 “Facilitating International Prospective Clinical Trials in Stem Cell Transplantation” project.....................................................................................................................................40 The Clinical Trials Directive: How Is It Affecting Europe’s Non-commercial Research?...40 Two years later: the impact of the EU Directive. Why Research in Europe has declined since the implementation of the Clinical Trials Directive .....................................................41 European Organisation for Research and Treatment of Cancer (EORTC) experience .........42 Forward Looks on Investigator-driven
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