versus industry driven clinical trials IDCTs

mutebabiesBiotechnology

Dec 6, 2012 (4 years and 11 months ago)

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Clinical trials in Framework programme 7 (FP7) EU

2007
-

2013

Judita Kinkorová


2. Národní konference o doporučených postupech, Olomouc

13. listopadu 2010

What is the 7th FP (7th Framework Programme)

Structure

CORDIS,

the Community
Research and
Development
Information
Service

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


Work programme 2011/1

1.
Strategic framework and responding to EU policy needs


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

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


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)

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.


Work programme 2011/3

1.
New key research challenges (alltogether 5)


3) Supporting
innovative clinical trials
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to verify safety and
efficacy

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/


Work programme 2011/4

1.
New key research challenges (alltogether 5)


4) How lifestyle affects health and how can this be mitigated

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/

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


Work programme 2011/3

3. OPTIMISING THE DELIVERY OF HEALTHCARE TO
EUROPEAN CITIZENS

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


EDCTP

European and Developing Countries Clinical Trials Programme

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

Thank you

Judita Kinkorová




kinkorova@tc.cz

724 543 043

Technologické centrum AV ČR

www.tc.cz


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