Clinical Trials as Instruments supporting Evidence-based ... - ECRIN

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Oct 4, 2013 (3 years and 9 months ago)

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The ESFRI
context.

Clinical
Trials as Instruments supporting Evidence
-
based Medical
Practice.



Dr

Rafael de
Andres

Medina, Instituto de Salud Carlos
III

rdam@isciii.e
s


www.isciii.es

,

DC


Day
3, Wednesday,

Embassy of
France to

the
United
States of America




An overview of the context

Washington, DC

4
-

6 June 2012

2

RDAM

Clinical
Trials
as
Instruments
Supporting
Evidence
-
based


Medical Practice

2006





2008





Should

provide

relevant

scientific

services
.


Promote

continuous

innovation
.


Business Plan.


Sustainability

ensured

by

self

committed

member

states
.


Predictable

Governnance
.


Science

is

scientists
´

driven
.


Fair

access

(
no
self

service
).


External

advisory

Board

-

helicopter

view
.


Financing

and
administration

is

member

state

driven
.


Used

to

have

each

own

legal
personnality
.


If

ERIC,
awarded

by

the

European

Commission
, VTA
exempt
.


Washington, DC

4
-

6 June 2012

RDAM


Biological and Medical
Sciences [BMS]

Research Infrastructures [RI
]


ESFRI

-

SWGs

assess

the

implementation

and
performance

3


BBMRI

-

Biobanks



Spain:
ISCIII

as funder with

63
biobanks
´

network
as Scientific partners



EATRIS

-

Translational Research Facilities


Spain:
ISCIII
as funder and
Health Research Institutes
´

network

as Scientific
partners


ECRIN

-

Clinical trial platform


Spain: ISCIII as funder

with
40 CRO
as Scientific partners


ELIXIR

-

Bioinformatics


Spain: ISCIII as funder with

and

INB
as
Scientific partner


INFRAFRONTIER
-

Mouse Models and Archives


I
NSTRUCT

-

Structural Biology Facilities


EMBRC

-

Marine Biology Resources


ERINHA
-

High
-
security labs


Spain:
ISCIII
as partner


EuroBioImaging

-

Cellular and Medical Imaging


EU
-
Openscreen

-

Chemical Libraries and Screening


ANAEE
-

Analysis and experimentation on ecosystems


ISBE



Infrastructure for
Systems
B
iology


EMBRC
-

European

Marine
Biological

Resource

Centre


MIRRI



Microbial resources

2006





2008



2010


Biological and Medical
Sciences [BMS]

Researhc

Infrastructures [RI
]

RDAM

Washington, DC

4
-

6 June 2012

4



Health

&
Food
.



Enviromental

&
Climate

Change
.


Energy
.


Social & Cultural
Innovation
.


Innovation

Technology

Transfer.


Regiona
I
.


Evaluation
.


Implementation
.

Washington, DC

4
-

6 June 2012

RDAM


Strategic Working Groups

[SWGs]

5


Investment

in
independent

clinical

trials

brings

major

added

value

for

European


R&D,
health

care

systems
,



patients

and
citizens
.

Washington, DC

4
-

6 June 2012


Policy

makers
´
s

and
public

understanding

and
effective

support
.


Need

for

independent

clinical


trials
.


Need

for

multinational

collaboration
.

6

RDAM

Washington, DC

4
-

6 June 2012


It applies
not only for
medicinal
products,

but
also for medical
devices.


Other
non
-
pharmacological interventions,
e.g.
rehabilitative
procedures and
surgical techniques
,

require
comparative clinical
trials too.



e.g. Relevant in Multi
-
morbidity / poly
-
pathology of ageing

populations that will require therapeutic combinations.


The goal of evidence
-
based
medicine.

7

RDAM

Washington, DC

4
-

6 June 2012


Basic
sciences,
particularly
the new


omics


methods, are leading
to
an important



change in the nomenclature
of
diseases
.


What
was considered a single disease is

now
dissected into various
strata.


Prevention and
p
redictive medicine.

8

RDAM


Relevat

for
distinct diagnostic and prognostic features
.


Need

for

independent

clinical

trials
.


Independent

evaluation

of
health

interventions

is

required


to

support

health

authorities
,
develop

health

care

policies


and
define
clinical

guidelines

for

healthcare

professionals
.



what

is

the

best

treatment

option

for

this

patient

/
disease

?”

rather

than



is

this

particular
product

effective

and
safe
?”



Highly

positive
return

on

investment

for

society
.


D
ecrease

in
the

burden

of
disease
,


O
ptimized

health

care

strategies
,


C
ost

containment

in
health

care

systems
.


Washington, DC

4
-

6 June 2012


what

is

the

best

treatment

option

for

this

patient

/
disease

?”

rather

than



is

this

particular
product

effective

and
safe
?”
.


To

get

robuster

evidence
.

9

RDAM


Need

for

multinational

collaboration
.


Rapid
assessment

of
the

effects

of
treatments
.


L
arge

and
diverse

populations
.


W
ider

applicability

of
study

results
.


M
ore
successful

adoption

in
national

health

care

systems
.


R
educe
inequalities

in
health

care
.


P
romotes

evidence
-
based

medical
practice
.



Access
to

larger

patient

populations

and
to

clinical

expertise
.


T
o

study

of
stratified

and
personnalised

treatment

strategies
.


T
o

study

on

rare

diseases

/
conditions
.


A
ccess
to

best

appropriate

medical centres.



Washington, DC

4
-

6 June 2012


Room

for

more
regulatory

collaboration

too
.

10

RDAM


We
need a
common vision and a shared
will.

Washington, DC

4
-

6 June 2012

11

RDAM

Many

thanks

for

your

attention

!!!