ICREL was a one-year project financed by the European 7th Framework Programme. Under EFGCP’s coordination, ECRIN, EORTC, as well as the Hospital Clínic of Barcelona and the Ethics Committee of the Medical University of Vienna collaborated in this project.
Its aim was to measure and analyse the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislations in the EU on all categories of clinical research and on the different stakeholders: commercial and non-commercial sponsors, ethics committees and competent authorities.
This initiative fits with the need to adapt the current legislation and will help determine the most relevant pathways for improvement.
The Directive 2001/20/EC was adopted with the objective of harmonising the EU regulatory environment for clinical research, of improving the protection of participants, of optimising the use of safety information, and of ensuring the credibility of data, through a strengthened responsibility of the sponsors and harmonized trial authorisation procedures for member states.
However, this legislation only protects participants in clinical trials on medicinal products. It requires almost similar procedures for all types of clinical trials with medicinal products from registration studies on innovative treatments to studies comparing treatment strategies using marketed drugs or applying minimally invasive procedures. The academic institutions and the industry, including SMEs, face major difficulties in fulfilling their sponsor’s responsibilities.
The Clinical Trials Directive’s objectives were transposed into divergent national legislations, partly missing the harmonisation goal and making especially multi-national trials difficult to perform. This raises concerns on the competitiveness and attractiveness of the EU for clinical research. The ICREL project was designed to measure the impact of the current EU legislation, analysing its direct and indirect consequences.
In order to reach a maximum of information, a survey was conducted.
The first results of this survey were presented and discussed during a conference in Brussels on 2 December 2008. The conclusions of the meeting are presented in the final report to the European Commission.
This report is being submitted to the European Commission, who has accepted its immediate publication. As a document from the FP7 programme, it is of public use. Please note that all elements included can be referred to, bearing in mind that they are presented in their specific context.
Statistical Report CA (Competent Authorities)
Statistical Report EC (Ethics Committees)
Statistical Report CS (Commercial Sponsors)
Statistical Report NCS (Non-Commercial Sponsors)
Appendix CA (Competent Authorities)
Appendix EC (Ethics Committees)
Appendix CS (Commercial Sponsors)
Appendix NCS (Non-Commercial Sponsors)
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