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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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Presentation Transcript
slide1
SWECRIN Meeting

September 2008

ECRIN-III Working Party 9

Communication

WP9 Lead Christian Gluud, DCRIN

Co-leads HHUD-KKS, UKCRN, ATCRIN

planned activities in the contract regarding communication
Planned activities in the contract regarding communication

Objectives

- Internal communication

- External communication

objectives
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

objectives1
Objectives

- Internal communication

- Website www.ecrin.org

- Newsletter ECRIN NEWS

…….to increase cohesion and

effectivity of ECRIN

slide7
ECRIN website

http://www.ecrin.org/

slide13
- 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?

slide14
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

slide15
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

slide17
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!

slide20
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!

slide21
Heiberg’s masterpiece

Heiberg even described an exact

equivalent to the famous statistical method

proposed by Mantel and Haenszel

more than 60 years later

slide22
Johannes Fibiger (1867-1928) seems to be the first who conducts a controlled clinical trial in Denmark
slide23
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)

slide24
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!)

objectives2
Objectives

- External communication

- ECRIN website (www.ecrin.org)

- ECRIN brochure

- ECRIN flyer

- International Clinical Trials’ Day

objectives3
Objectives

International Clinical Trials’ Day

20th May

EACH YEAR SINCE 2005

slide28
James Lind 1716-1794

First known trial in man

objectives4
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’

slide32
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 [email protected] + 33 1 44 23 62 85

Executive Manager

Christine [email protected] + 33 1 44 23 62 78

Network Committee

Chair, Network Committee

Christian Ohmann KKS Duesseldorf, Germany [email protected]

Scientific Board

Scientific Secretariat

Vittorio Bertele Instituto Mario Negri, Italy [email protected]

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

slide33
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.

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4

5

current status
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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