2.O.11 ESF-EMRC FORWARD LOOK INVESTIGATOR-DRIVEN CLINICAL TRIALS: KEY RECOMMENDATIONS FOR STRENGTHENING PATIENT ORIENTED RESEARCH IN EUROPE

Abstract

Investigator-Driven Clinical Trials (IDCT) form a key part of patient-oriented clinical research, the basis for continually improving patient care. Such research is under strain in Europe for a multiplicity of reasons, and because of this the European Medical Research Councils (EMRC) of the ESF has undertaken in 2007 a Forward Look exercise. This Forward Look represents what is probably the most comprehensive examination of IDCT in Europe in recent years. A thorough analysis of the problems faced by academic investigators conducting IDCT was carried out through a series of workshops covering different themes and attended by active and acknowledged experts in the field. These workshops identified specific issues that need to be addressed:

• - Categories and Design of Investigator-Driven Clinical Trials

• - Regulatory and Legal Issues, Intellectual Property Rights and Data Sharing

• - Management of Investigator-Driven Clinical Trials

• - Education, Training, Career Tracks and Authorship

• - Funding and Models of Partnership

• - Status of Investigator-Driven Clinical Trials in Central and Eastern European Countries

A range of possible solutions were proposed and five among the 26 recommendations as ranked by the consensus conference, held on 29–30 September 2008, were considered as top priorities to strengthen IDCT in Europe:

1. To improve the education, training and career structure for scientists involved in patient-oriented clinical research.

2. To increase levels of funding for IDCT.

3. To adopt a ‘risk-based’ approach to the regulation of IDCT.

4. To streamline procedures for obtaining authorisation for IDCT.

5. To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results – that the trials are ‘correctly powered’.

To help implement the recommendations expressed in the report for strengthening patient oriented research in Europe a broad dissemination to the four stakeholder groups identified as key players will be assured.We clearly think that if we can collaborate on this important issue and improve conditions for clinical research, we can contribute to bringing better health and prosperity to Europe.