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European Clinical Researchin a Global Setting
FEAM Launch Event25 January 2011
European Medical Research CouncilsDr Stephane Berghmans
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ESF Member Organisations
ESF is an independent association of 79 Member Organisations research funding organisations research performing organisations academies and learned societies
in 30 countries
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European Medical Research Councils
The membership organisation for the medical research councils in Europeunder the ESF
EMRC founded 1971
Chair Prof L. HøjgaardClinical Physiology,Nuclear Medicine & PETRigshospitaletUniversity of Copenhagen
(DK)
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1. Basic Research
2. Translational Research
3. Clinical Research
4. Epidemiology & Prevention
Medical Research
Promote innovative medical research and its clinical application towards improvedhuman health
EMRC’s Mission
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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’
Forward LooksInvestigator-Driven Clinical Trials
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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’
Forward LooksInvestigator-Driven Clinical Trials
www.esf.org
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’
Forward LooksInvestigator-Driven Clinical Trials
www.esf.org
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’
Forward LooksInvestigator-Driven Clinical Trials
www.esf.org
1. Multiple and divergent assessment of CTs
2. Definitions3. Safety reporting4. Substantial amendments5. Labelling6. Sponsor issues7. Emergency in CTs8. Monitoring9. General recommendations
outside the CTD
Position Paper
EMRC proposal for a revision of CTD & recommendations for CT facilitation
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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’
Forward LooksInvestigator-Driven Clinical Trials
www.esf.org
Global Setting
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Global Setting
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Global Setting
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Global Setting
OECD Global Science Forum“Towards international recommendations to facilitate cooperation in international non-commercial clinical trials”
• ESF-EMRC implementation workshop (Paris, June 2009)
• German and Spanish governments support
• OECD GSF proposal approved (April 2010)
• First GSF meeting (Madrid, May 2010)
• Second GSF meeting (Washington, November 2010)
• Final GSF meeting (Berlin, May 2011)
• Participants: European Commission, ESF, FDA, WHO, Germany, Spain, France, UK, Poland, Denmark, Norway, New Zealand, USA, Canada, Japan, South Africa, etc.
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Global Setting
• Survey (Done) • Regulatory differences• Current situation for education, training & infrastructure
• Working Groups (in progress, finalisation May 2011)• Risk-based approach to CTs• Regulatory frameworks & harmonisation• Infrastructure, education & training practices
• Report including recommendations (October 2011)
OECD Global Science Forum“Towards international recommendations to facilitate cooperation in international non-commercial clinical trials”
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Thank you
Dr Stephane Berghmans, Head of Unit
Dr Kirsten Steinhausen, Science OfficerMedical SciencesEuropean Science Foundation (ESF)
[email protected]@esf.org1 quai Lezay-Marnésia - BP 9001567080 Strasbourg cedex – FranceTel +33 (0)3 88 76 71 63www.esf.org/emrc
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Global Setting
