Involvement of ESF and EMRC in Clinical Trials Wellcome Trust, London, 16 March 2010 by Dr. Maria Manuela Nogueira ESF Science Officer.

Transcription

1 Involvement of ESF and EMRC in Clinical Trials Wellcome Trust, London, 16 March 2010 by Dr. Maria Manuela Nogueira ESF Science Officer 1

2 ESF Member Organisations ESF is an independent nongovernmental organisation of 79 Member Organisations research funding organisation research performing organisations academies and learned societ in 30 countries 2

3 About ESF Established in 1974 Offices in Strasbourg, Brussels, Ostend ESF headquarters, Strasbourg ESF budget: 58M in 2009 Staff: equivalent to 152 full time in 2009 Marine Board, Ostend Research Conferences Unit,15 th floor and COST, 21 st floor, Tour Generali, Brussels 3

4 ESF covers all scientific domains Standing Committee domains Humanities Social Sciences Life, Earth & Environmental Sciences Medical Sciences Physical and Engineering Sciences Expert Board/Committee domains Marine Sciences Polar Sciences Space Sciences Radio Astronomy Nuclear Physics Materials Science 4

5 European Medical Research Councils EMRC is the membership organisation for the medical research councils in Europe under the ESF, founded in Chair: Prof Liselotte Højgaard Clinical Physiology, Nuclear Medicine & PET, Rigshospitalet, University of Copenhagen (DK) 5

6 EMRC s Mission Promote innovative medical research and its clinical application towards improved human health. Medical Research 1. Basic Research 2. Translational Research 3. Clinical Research 4. Epidemiology & Prevention 6

7 ESF Activities Strategic Plan SCIENCE STRATEGY Forward Looks Science Policy Briefings Exploratory Workshops SCIENCE SYNERGY EUROCORES Research Programmes Research Networking Programmes Research Conferences SCIENCE MANAGEMENT Peer Review support Coordination of EUROHORCs projects Coordination of ERA projects Implementing agent for the COST office through EC contract Member Organisation Fora 7

8 EUROCORES (European Collaborative Research Programmes) Unique investigator-driven collaborative research scheme in Europe Opportunity for science community and ESF Member Organisations to submit ideas for medium- to large-scale collaborative research programmes International peer review Research funding remains national, networking and dissemination funded through ESF Typically channels 5-10M over 3 years across 5-15 collaborative research programmes, with up to 80 individual projects 8

9 ECT (Pan-European Clinical Trials) Resulting from 2001 Call for Proposals Launched in January Collaborative Research Programmes: EURAMOS (Project Leader: Prof. Stefan Bielack, DE) PROFIDYS (Project Leader: Prof. Philippe Orcel, FR) 14 Individual Projects: 7 for EURAMOS (+ 6 Associated Partners) - Budget (including research): for PROFIDYS - Budget (including research): Belgium, Denmark, Finland, France, Germany, The Netherlands, Norway, United Kingdom Currently in Networking and Dissemination phase: Jan May

10 ECT activities Training courses on clinical trials Oral presentations at various annual meetings and congresses: SIOP, EMSOS, CTOS, ECCO, SMS Networking meetings Conferences: Global PROFIDYS Conference Stuttgart Conference on Pan-European Sarcoma Trials Article on Pan-European Sarcoma Trials in The Lancet Oncology, Jan Art exhibition from young bone cancer patients Translation of PROFIDYS website into English, Dutch and German 10

11 Forward Look IDCT 2008: 6 workshops and consensus conference March 2009: publication of Forward Look Report Investigator-Driven Clinical Trials (IDCT) June 2009: top five recommendations analyzed in a workshop Now in implementation phase 11

12 Top 5 recommendations 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. 12

13 Top 5 recommendations 2. To increase levels of funding for IDCT Improvements through: -EU Framework Programme 7 ( calls) -EU Framework Programme

14 Top 5 recommendations 3. To adopt a risk-based approach to the regulation of IDCT OECD Global Science Forum -German and Spanish initiative -Scoping Group (European Commission, Finland, France, Germany, Japan, New Zealand, Norway, Spain, United States) meeting at OECD (Paris) on 5 March

15 Top 5 recommendations 4. To streamline procedures for obtaining authorization for IDCT Improvements through: -EU Clinical Trials Directive revision -EMRC Expert Group -Support from NIH 15

16 Thank you for your attention Contact points: Dr. Maria Manuela Nogueira Science Officer EUROCORES Coordinator Medical Sciences Unit T: mnogueira@esf.org Dr. Stephane Berghmans Head of Medical Sciences Unit T: sberghmans@esf.org European Science Foundation 1 quai Lezay-Marnésia BP Strasbourg Cedex France 16

17 Back-up slides 17

18 Setting Science Agendas for Europe The European Science Foundation provides a common platform for its Member Organisations in order to: advance European research explore new directions for research at the European level Through its activities, the ESF serves the needs of the European research community in a global context. Its mandate is underpinned by the values of excellence, openness, responsiveness, pan- European, ethical awareness and human values. 18

19 Range of Instruments Funding available to researchers EUROCORES Funding level 1 m 100 k Conferences RNPs 15 k Exploratory Workshops Number of researchers per instrument 19

20 ECT (Pan-European Clinical Trials) 20

21 Forward Looks Medium to long-term scientific perspectives Multidisciplinary topics viewed at a European level Bring together scientists with policy makers Wide consultation Result in major reports and action plans

22 Forward Look IDCT 22

23 Science Policy Briefings Address science policy issues of key concern to the ESF Member Organisations and the wider scientific community Draw on the advice and expertise of researchers Provide consensus on strategy recommendations to policy makers

24 Open Calls for Proposals ESF issues annual calls for proposals for: Exploratory Workshops Research Conferences Research Networking Programmes EUROCORES themes and projects