ICREL is 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 collaborate in this project.

Its aim is to measure and analyse the direct and indirect impact of the Clinical Trials Directive 2001/20/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 current project is designed to measure the impact of the current EU legislation, analysing its direct and indirect consequences.

In order to reach a maximum of information, we need your help!

Those of you who are clinical research stakeholders (sponsor of clinical trials or Ethics Committee or Competent Authority), please answer to the questionnaire accessible here.

The results of this project will be presented and discussed during a workshop in Brussels on 2 December 2008. The conclusions of the meeting will be presented in the final report to the European Commission, together with the recommendations for legislative environment changes. You are welcome to join the conference (registration will be needed). The results and conclusions will be published and disseminated.

We remain at your disposal whenever you wish so: icrel@efgcp.be

Thank you!

The ICREL Team