Transcript No Slide Title

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
- External communication
Internal communication
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
Objectives
- Internal communication
- Website
www.ecrin.org
- Newsletter
ECRIN NEWS
…….to increase cohesion and
effectivity of ECRIN
ECRIN website
http://www.ecrin.org/
- ECRIN PEOPLE: I form, 200 words, picture
Jacques Demotes-Mainard, France
Christian Ohman, Germany
Silvio Garattini, Italy
- 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?
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 (18141884) already in 1839.
Fenger had heard Gavarret lecture in
Paris
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
Povl Heiberg (1868-1963)
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
contemporary the article is!
how
Heiberg’s masterpiece
republished in 2008 on
www.jameslindlibrary.org
Heiberg’s masterpiece
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!
Heiberg’s masterpiece
Heiberg even described an exact
equivalent to the famous statistical method
proposed by Mantel and Haenszel
more than 60 years later
Johannes Fibiger (1867-1928) seems to
be the first who conducts a controlled
clinical trial in Denmark
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)
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!)
External communication
Objectives
- External communication
- ECRIN website (www.ecrin.org)
- ECRIN brochure
- ECRIN flyer
- International Clinical Trials’ Day
Objectives
International Clinical Trials’ Day
20th May
EACH YEAR SINCE 2005
James Lind 1716-1794
First known trial in man
20th May 1747
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’
Thank you!
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 Kubiak
[email protected]
+ 33 1 44 23 62 78
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.
Network Committee
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.
Chair, Network Committee
Christian Ohmann
KKS Duesseldorf, Germany
[email protected]
Scientific Board
Scientific Secretariat
Vittorio Bertele
Instituto Mario Negri, Italy
[email protected]
Integrating clinical
research in Europe
www.ecrin.org
ECRIN mission statement
Mission
This multinational and distributed
infrastructure 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.
Aims
ECRIN 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
2
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
4
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
comprehensive support 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
5
programme.
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!