1. Clinical trials in Framework programme 7 (FP7) EU 2007 - 2013 Judita Kinkorová 2. Národní konference o doporučených postupech, Olomouc 13. listopadu 2010

2. What is the 7th FP (7th Framework Programme) Structure

3. CORDIS, the Community Research and Development Information Service

4. Priority Health structure pillar 1: Biotechnology, generic tools & technologies for health pillar 2: Translating research for human health pillar 3: Optimising the delivery of health care cross-cutting issues: child health, the health of ageing population gender-related health issues Activity (pillar) 4: Other actions across the theme

5. Work programme 2011/1 1.Strategic framework and responding to EU policy needs investigator-driven clinical trials 1.In order to boost innovative drugs and health solutions in EU the Health Theme makes major effort into investigator-driven clinical trials in various fields 2.Main focus: 1.brain related diseases, 2.diabetes, 3.Cancer, 4.Antimicrobial drug resistance 5.Emerging epidemics

6. How EC udnerstand and support investigator driven clinical trials(IDCTs) versus industry driven clinical trials IDCTs – initiated by academic researchers, aimed to acquiring scientific knowledge and evidence to improve patient care IDCTs deal with potential diagnostic and therapeutic innovations x commercial interest: orpgan diseases comparison of diagnostic and therapeutic interventions, novel indications for registered drugs IDCTs have much broader scope and potential impact IDCTs – form a key part of patient oriented clinical resarch IDCTs – create the basis for continually improving patient care

7. Work programme 2011/2 1.New key research challenges (alltogether 5) 2) Two pilot actions for high impact research initiatives (large- scale integrating research projects, up to EUR 30 million) comparative clinical trials Epigenomics. This pilot action will be launched to integrate several components, such as epigenomic mapping in health and diseases, high-throughput technology, diagnostic tools, targeted intervention drug screening in the context of comparative clinical trials. This integrated research effort should contribute to understanding diseases and the impact of lifestyle on health. It will integrate research activities and structure the ERA in a global context on an unprecedented scale in this emerging field of research.

8. Work programme 2011/3 1.New key research challenges (alltogether 5) innovative clinical trials 12 3) Supporting innovative clinical trials 12 to verify safety and efficacy clinical trials investigator-driven clinical trials clinical practice The aim is to strengthen clinical research in Europe in a number of areas with unmet medical needs. Specific actions under clinical trials listed in this work programme (especially under investigator-driven clinical trials) will have a major European added value into translating research to clinical practice. The objective is increasing therapeutic options for patients, stimulating the implementation of best practice in all Member States (MS) and in establishing the basis for a coherent programme addressing the issue of personalized medicine and improved therapeutic outcomes. 12 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eu dralex/vol-10/

9. Work programme 2011/4 1.New key research challenges (alltogether 5) 4) How lifestyle affects health and how can this be mitigated clinical trials Lifestyle determinants: diabetes, obesity and cardiovascular diseases. The emphasis is on clinical trials, prevention, epidemiology and controlled intervention. Actions include research on lifestyle and/or therapeutic approaches for diabetes; controlled intervention trials on lifestyle changes and concomitant therapeutic intervention on high-risk populations and on epidemiological studies on obesity. Coordination with Theme 2 'Food, Agriculture and fisheries, and Biotechnology' ('KBBE') is foreseen on diet/nutrition and disease development. There could be a strong component of international cooperation, throughglobal approaches, on diabetes / obesity and on early life programming. 12 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eu dralex/vol-10/

10. Priority Health structure pillar 1: Biotechnology, generic tools & technologies for health pillar 2: Translating research for human health pillar 3: Optimising the delivery of health care cross-cutting issues: child health, the health of ageing population gender-related health issues Activity (pillar) 4: Other actions across the theme

11. Work programme 2011/3 3. OPTIMISING THE DELIVERY OF HEALTHCARE TO EUROPEAN CITIZENS clinical research outcome into clinical practice 3.1 Translating the results of clinical research outcome into clinical practice including better use of medecines, and appropriate use of behavioural and organisational interventions and new health therapies and technologies 3.2 Quality, efficiency and solidarity of healthcare systems including transitional health systems 3.3 Health promotion 3.4 International public health & health systems

12. EDCTP European and Developing Countries Clinical Trials Programme The European & Developing Countries Clinical Trials Partnership The European & Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases of HIV/AIDS, malaria and tuberculosis. These diseases account for over 6 million deaths each year, and the numbers are growing. Sub-Saharan Africa is the world's worst-affected region where besides ravaging lives, they impede development and cause poverty. Member states: Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom http://www.edctp.org/Home.162.0.html

13. Thank you Judita Kinkorová kinkorova@tc.cz 724 543 043 Technologické centrum AV ČR www.tc.cz 13