Roadmap Initiative for Clinical Research in Europe – Final Workshop

Designing the Future Conditions for Clinical Research in Europe

17 March 2010, Diamant Centre, Brussels, Belgium

All stakeholders in the clinical research process agree that the planning and performance of clinical trials is unnecessarily complex in Europe as a result of the introduction of the new legislation in 2004 without a measurable improvement of clinical trial participant safety and quality of the data. And many clinical researchers complain that important trials are not performed due to the complexity and related costs of clinical trial organisation in the current environment. Research on the situation like the ICREL Project has provided reliable data on the current situation and encouraged the need for developing solutions. The “Roadmap Initiative for Clinical Research in Europe” has identified the bottlenecks and performed 5 workshops (Single CTA, Co-Sponsorship, Risk-based Approach, Ethical Review, and Safety Reporting) to discuss options for solutions with all different stakeholders involved in the process. The results of these workshops were or are in the process of being reported. Highly interesting, innovative proposals were made – partly broadly agreed and partly controversially discussed. The aim of the Roadmap Initiative is to further debate these proposals and to prepare a list of items for the European Commission to radically improve the situation for clinical research in Europe. This may need new legislation, change of the current legislation and/or adaptation of the current guidelines for implementation in the Member States.

In this Final Workshop the proposals made in the Workshops will be summarized and discussed by all stakeholders involved, further optimized and prioritized with the aim to design a proposal to the Commission for an overall new regulatory environment for clinical trials in Europe that attracts and encourages clinical research in Europe to the benefit of the patients.

Report of the Workshop on the Single CTA (7 July 2009)

Report of the Workshop on Co-Sponsorship (21 September 2009)

Report of the Workshop on Risk-based Approach (18 January 2010)

Report of the Workshop on Ethical Review (19 January 2010)

Report of the Workshop on Pharmacovigilance (8 February 2010)

EPPOSI Workshop on Clinical Trials (22 April 2009)