FL 07-001 'Investigator-Driven Clinical Trials'

Project Number FL 07-001


Professor Jürgen Schölmerich, DFG & University Medical Center, Regensburg, Germany


Professor Håkan Billig, SRC & Göteborg University, Göteborg, Sweden
Professor Roger Bouillon, FWO & Katholieke Universiteit, Leuven, Belgium


Improved patient-oriented research in Europe will benefit European citizens and the European medical industry and facilitate the transfer of scientific discoveries from the laboratory bench to the bedside. For Europe and for the rest of the world this effort will be of great importance for the quality of life of individuals and the wellbeing of society as a whole.
To achieve this important objective, the European Medical Research Councils (MED (formerly EMRC)) at the ESF mandated the undertaking of a Forward Look on ‘Investigator-Driven Clinical Trials’.
This consisted of a state-of-the-art analysis of the current problems faced by academic investigators when initiating clinical trials in Europe and the identification of the investigators’ needs.
This was achieved by organising a consultation process involving high-level experts already engaged in a similar strategic approach at a national, pan-European or international level and focusing on key issues discussed under the format of five strategic workshops:

  1. Categories and Design of Investigator Driven Clinical Trials
  2. Regulatory and Legal Issues, Intellectual Property Right (IPR) and Data Sharing
  3. Management of Investigator-Driven Clinical Trials
  4. Education, Training, Career and Authorship
  5. Funding and Models of Partnerships

The outcome of the consultation process, including recommendations for how to solve the identified problems and address the specific needs, was presented to and further challenged by a broader high-level audience participating in a consensus conference held under the label of the French Presidency of the European Union on 29-30 September 2008, Strasbourg, FR. This group of acknowledged experts was also requested to prioritise the top five recommendations, i.e.:

  1. To improve the education, training and career structure and opportunities 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 authorization for IDCT.
  5. To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results so that the trials are ‘correctly powered’.

The Forward Look makes recommendations on how to strengthen patient-oriented research with the aim of improving clinical research in Europe and thereby securing better health and welfare for the European community.
As science is global, strengthened medical research in Europe will also benefit the rest of the world.


The report of the Forward Look exercise has been published on 12 March 2009 and a Science Policy Briefing aimed at highlighting the next steps to implement the recommendations is currently under preparation.