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SWECRIN Meeting September 2008 ECRIN-III Working Party 9 Communication

SWECRIN Meeting September 2008 ECRIN-III Working Party 9 Communication WP9 Lead Christian Gluud, DCRIN Co-leads HHUD-KKS, UKCRN, ATCRIN. ECRIN - a one-stop clinical research shop. Planned activities in the contract regarding communication. Objectives - Internal communication

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SWECRIN Meeting September 2008 ECRIN-III Working Party 9 Communication

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  1. SWECRIN Meeting September 2008 ECRIN-III Working Party 9 Communication WP9 Lead Christian Gluud, DCRIN Co-leads HHUD-KKS, UKCRN, ATCRIN

  2. ECRIN - a one-stop clinical research shop

  3. Planned activities in the contract regarding communication Objectives - Internal communication - External communication

  4. Internal communication

  5. Objectives - Internal communication -ECRIN is growing - ECRIN should function as a ‘one-stop shop’ -WE have got to know ECRIN - WE have got to know each other

  6. Objectives - Internal communication - Website www.ecrin.org - Newsletter ECRIN NEWS …….to increase cohesion and effectivity of ECRIN

  7. ECRIN website http://www.ecrin.org/

  8. - ECRIN PEOPLE: I form, 200 words, picture

  9. Jacques Demotes-Mainard, France

  10. Christian Ohman, Germany

  11. Silvio Garattini, Italy

  12. - News from ECRIN: deliverables, SOPs, meetings, workshops - News regarding trials - Trial of the year (planned) -Introduction of EBM in your country: who, what, when was the first trial conducted?

  13. Early clinical trials in Denmark By Christian Gluud, DCRIN The ideas of evidence-based clinical practice form France expressed so elegantly by LDJ Gavarret in 1840 came to Denmark with Carl Emil Fenger (1814-1884) already in 1839. Fenger had heard Gavarret lecture in Paris

  14. Inspired by great mathematical statisticians like TN Thiele and H Westergaard, Povl Heiberg (1868-1963) seems to be the first to clearly formulate in Danish the requirements for obtaining evidence in 1897

  15. Povl Heiberg (1868-1963)

  16. Heiberg’s masterpiece entitled ‘Studies on the statistical study design as an aid in therapeutic trials’ was published in Bibliotek for Læger [Library for Physicians] 1897;89:1- 40 - You will be surprised how contemporary the article is!

  17. Heiberg’s masterpiece republished in 2008 on www.jameslindlibrary.org

  18. Heiberg’s masterpiece

  19. Heiberg’s masterpiece Heiberg describes the necessity to conduct randomised trials with blinding - to avoid systematic errors - and large sample sizes - to avoid random errors!

  20. Heiberg’s masterpiece Heiberg even described an exact equivalent to the famous statistical method proposed by Mantel and Haenszel more than 60 years later

  21. Johannes Fibiger (1867-1928) seems to be the first who conducts a controlled clinical trial in Denmark

  22. Johannes Fibiger (1867-1928) seems to be the first who conducts a controlled clinical trial in Denmark The trial included diphtheria patients during 1896 to 1897 and was published in 1898 (Fibiger was awarded the 1926 Nobel Prize in Physiology and Medicine)

  23. Johannes Fibiger (1867-1928) seems to be the first who conducts a controlled clinical trial in Denmark The trial included diphtheria patients during 1896 to 1897 and was published in 1898 (Fibiger was awarded the 1926 Nobel Prize in Physiology and Medicine for false findings!)

  24. External communication

  25. Objectives - External communication - ECRIN website (www.ecrin.org) - ECRIN brochure - ECRIN flyer - International Clinical Trials’ Day

  26. Objectives International Clinical Trials’ Day 20th May EACH YEAR SINCE 2005

  27. James Lind 1716-1794 First known trial in man

  28. 20th May 1747

  29. Objectives - External communication - Guerrilla marketing!!!! - We all speak positively about ECRIN - We all speak about ECRIN once a day - We all include ECRIN in our publications - We all use ECRIN as one of our ‘departments of origin’

  30. Thank you!

  31. The ECRIN infrastructure links national networks of clinical research centres and clinical trials units, providing support to any type of clinical research, in any medical field. Users will be investigators and sponsors in both academic and industry sectors. Contact ECRIN Coordination Programme Coordinator Jacques Demotes-Mainard jacques.demotes@inserm.fr + 33 1 44 23 62 85 Executive Manager Christine Kubiakchristine.kubiak@inserm.fr + 33 1 44 23 62 78 Network Committee Chair, Network Committee Christian Ohmann KKS Duesseldorf, Germany ohmannch@uni-dusseldorf.de Scientific Board Scientific Secretariat Vittorio Bertele Instituto Mario Negri, Italy bertele@marionegri.it Vision ECRIN is the European infrastructure for clinical research, facilitating clinical research in the European Union, taking advantage of its population size and of its high healthcare standards, and improving quality and transparency for the benefit of patients, citizens and healthcare systems. • Services: • support in the interaction with ethics committees • support in the interaction with competent authorities and regulatory requirements • support in adverse event reporting • support in drug dispensing • support in the circulation of biological samples • support in study monitoring • data management for multinational studies • good manufacturing practices (GMP) of biotherapy products • patient recruitment and investigation. Integrating clinicalresearch in Europe www.ecrin.org

  32. ECRIN mission statement Mission This multinational and distributedinfrastructure makes the European Union an integrated area for clinical research, unlocking latent scientific potential, spreading best practices and highest quality standards, thus fostering the attractiveness of Europe for clinical research and increasing the competitiveness of European biomedical research for academic institutions, small- and medium sized enterprises, and health industry. AimsECRIN provides integrated ‘one-stop shop’ support to investigators and sponsors in multinational clinical research projects, for any category of clinical research, in any disease area, particularly in rare diseases where multinational collaboration is a critical success factor. ECRIN promotes the development of national networks of clinical research centres and clinical trial units with professional staff and data management tools, implementing high quality standards in the conduct of clinical studies. ECRIN promotes education and training, as well as mobility programmes between countries, between preclinical and clinical research, and between academia and industry. ECRIN facilitates the connection of disease-oriented networks across borders. ECRIN promotes sound, unbiased methodology ensuring optimal protection of trial participants and high ethical standards. ECRIN promotes availability and EU integration of funding to clinical research projects. ECRIN promotes harmonisation of national legislation on clinical research and the development of a European regulatory framework providing optimal protection for the trial participants and minimal obstacles to medical institutions, through requirements adapted to the risk of the individual trial. ECRIN promotes transparency and optimal use of data through public registration of clinical studies, transparent reporting, and the development of public repositories for clinical study data. ECRIN promotes the active participation of patients in clinical research, through their involvement in every step including the initiation and design of clinical studies. ECRIN promotes communication on the challenges raised by clinical research with patients, families, citizens, ethics committees, competent authorities, academic and industry sponsors, news media, national and EU policy makers, and other stakeholders. ECRIN acts synergistically with the other EU biomedical infrastructures involved in preclinical research and biobanking, promoting common strategies, shared procedures and interoperable data, thus providing a comprehensivesupport to biomedical science in the EU. ECRIN plans extension to all the EU member and associated states, develops partnership with clinical research infrastructures in other world regions, and with developing countries through its capacity building programme. 2 4 5

  33. Current status • In preparation - International Clinical Trials’ Day 2009 Speakers invited • Still to be done - Website improvements and ECRIN NEWS - International Clinical Trials’ Day 2010 - Get ECRIN on the map!

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