CLINT

- Road Map Intiative: an introduction. To download pdf version, click here
- Schedule of Forthcoming Workshops & Related Documents

Final Stakeholder Workshop

Designing the Future Conditions for Clinical Research in Europe
17th March 2010
Diamant Centre
Brussels, Belgium

-Click here to download Preliminary Programme and further meeting information
-To register visit the EFGCP website

A Road Map Initiative for Clinical Research in Europe

This initiative brings together representatives of academic and not-for-profit organisations who have been involved in EU-funded projects to investigate different aspects of the clinical trials environment in Europe following implementation of the Clinical Trials Directive (DIR 2001/20/EC) and/or to promote academic clinical trials.

The various groups first came together in October 2008 at a meeting organised by the CLINT project to discuss the main recommendations arising from each project with a view to developing joint recommendations to the EU. Having identified a number of topics of common concern, the partners agreed to collaborate in exploring these issues further through a series of stakeholder workshops aimed at developing a body of recommendations to feed into a review of DIR 2001/20/EC planned by the European institutions in 2010. The series of workshops aims to bring together all of the relevant stakeholders (commercial and non-commercial sponsors, investigators, ethics committees, competent authorities and patients) and the outcomes of the workshop will culminate in a Stakeholder Conference in April 2010 to which representatives of DG SANCO, DG Enterprise and DG Research will be invited to participate.

The main goal of the Road Map Initiative is to work towards suggestions for improvement in potential new legislation with the aim of facilitating the performance of clinical research for the benefit of patients and to increase the competitiveness of clinical research on a European level. In order to be heard It is essential to have a united academic voice, which was missing during the development of the Directive. The Initiative is open to representatives from all stakeholder groups with an interest in supporting the development of broadly agreed elements for improved clinical trials legislation.

Key partners in this initiative have undertaken to take the lead in organising one or more of the workshops aimed at exploring possible solutions to the most critical obstacles to clinical trials in Europe.

Schedule of workshops and related documents:

Month	Venue	Topic	Organised by	Agendas	Meeting Report
7th July 2009	Brussels	Single Clinical Trial Approval (CTA) Process	EFGCP
21st Sept 2009	London	Co-sponsorship and contractual issues	CLINT/EBMT
18th - 19th Jan 2010	Barcelona	Risk-based approach and Ethics Committees	ECRIN	18th Jan 19th Jan
8th Feb 2010	Brussels	Pharmacovigilance	EORTC
17th Mar 2010	Brussels	Stakeholder Conference with EU	EFGCP

Possible solutions identified for exploration with stakeholders through these workshops:

To require only one Clinical Trials Authorisation (CTA) irrespective of the numbers of participating nations, either by the development of a single CTA application across Europe or the mutual recognition of authorisations by Competent Authorities.
To simplify and harmonise the procedures for clinical trial approval (e.g. the EudraCT forms as a single set of forms to be completed) and safety reporting (Eudravigilance and reporting rules).
To define better and harmonise the roles of the ethics committees (achieve the so-called single-opinion) and of the competent authorities.
To adopt a risk-based approach: adaptation of the regulatory requirements considering the risk associated with the trial with regard to the safety reporting (e.g. limited safety reporting for commercially approved drugs), data monitoring, insurance, application dossiers, substantial amendments, free-of-charge supply of drug (e.g. not in case of market approval).
To allow co-sponsorship in the case of multinational trial with the aim of facilitating collaboration between research groups.
To better define terms and concepts (IMP, interventional study, substantial amendment, etc.).
To increase public financial support to investigator-led clinical trials.
To harmonise insurances requirements e.g. uniform costs per country, minimum and maximum.
indemnity payments, total duration of coverage, time to permit claims etc.

Collaborating organisations and projects behind this initiative:

CLINT:

EBMT:

ECRIN:

EFGCP:

EORTC:

ELN:

ICREL:

Facilitating international prospective clinical trials in stem cell transplantation
(EU funded project)

European Group for Blood and Marrow Transplantation

European Clinical Research Infrastructures Network

European Forum for Good Clinical Practice

European Organisation for Research and Treatment of Cancer

European Leukaemia Net (EU funded project)

Impact on Clinical Research of European Legislation
(EU funded project – ended in Jan 2009)

Contact for information:

For further information about how to join this initiative or how to register for a workshop contact:

Fanny Senez
Chief Operating Officer, EFGCP
Tel: 00 32 2 732 87 83
Fax: 00 32 2 503 31 08
roadmapforCRinEurope@efgcp.org