This project aims primarily at analysing and measuring the impact of Directive 2001/20/EC (Clinical Trials Directive, CTD) and related legislation on the industry and academic clinical research with medicinal products but also on their impact on clinical research in the broader sense. This initiative fits with the need to provide evidence for a potential reconsideration of certain aspects of the current legislation and the elaboration of suitable approaches to national implementation of the CTD. The CTD was adopted with the objective of harmonising the EU regulatory environment for medicinal products, 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 Member States. 3.5 years after implementation of the CTD it appears that some of these aims have been reached more than others. The aim of harmonisation, however, has clearly not been reached. As this Directive’s scope is limited to medicinal products it does not harmonise all other areas of clinical research in a consistent way, especially as some EU Member States choose to implement the CTD in new clinical research legislation with wider scope than the Directive’s. As a result, also other types of clinical research face now different conditions in different EU Member States. Especially the performance of large multi-national clinical trials suffers from this lack of harmonisation. This raises concern on the competitiveness and attractiveness of the EU for clinical research. In an attempt to achieve the same quality standards almost similar procedures for all types of clinical trials with medicinal products are required – from registration trials with innovative treatments to trials comparing treatment strategies using marketed drugs and minimally invasive trials. Especially SMEs and academic institutions face major difficulties in fulfilling their sponsor responsibilities. This ICREL project is designed to create objective and reliable data on the impact of the CTD and related legislation on clinical research in Europe by measuring clinical research activities and conditions for clinical trials sponsored by big Pharmaceutical Industry and SMEs as well as non-commercial institutions, and by analysing its direct and indirect consequences on all types of clinical research and stakeholders through validated methods of information compilation and surveys: WP 2: Impact on big Phamaceutical Industry and SME sponsored clinical trials: WP 3: Impact on non-commercially sponsored clinical trials; WP4: Impact on clinical trials other than clinical trials on medicinal products; WP 5: Impact on Competent Authorities, pharmacovigilance, monitoring, clinical trials infrastructure and funding; WP 6: Impact on ethics committees an don participant protection The results of this project will be discussed during a final meeting with all involved stakeholders and broadly disseminated. The participants are institutions involved in various aspects of clinical research at the EU level, able to collect data from experts and organisations all over Europe, to analyse and interpret the results and to disseminate the consolidated conclusions to their communities (industry, academic research, competent authorities, ethics committees) and the public at large e.g. through publications, conferences and web pages.
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