Download PATHOS PRA CTICE PREDICT

WHY PREPARE
PREPARE Platforms
PREPARE is a EU funded network for
harmonized large-scale clinical research
studies on infectious diseases (IDs),
prepared to rapidly respond to any severe
ID outbreak, providing real-time evidence
for clinical management of patients and for
informing public health responses.
PREPARE will establish a common European
clinical research infrastructure covering over
600 primary care sites and over 600 hospital
sites in 27 EU member States.
‘Inter-epidemic’ studies will train PREPARE in
mounting a rapid, coordinated deployment
of Europe’s clinical investigators, within
48 hours of a severe outbreak. As such,
PREPARE aims to be at the basis of
establishing a paradigm shift in clinical
research in response to severe ID outbreaks.
A key lesson from a series of recent epidemics of emerging
pathogens of global public health importance (e.g., the 2009
H1N1 influenza pandemic) was that implementing clinical
research in response to a rapidly emerging ID is extremely
challenging and often delayed.
PRACTICE is the central clinical research platform of PREPARE. It
harbours the clinically oriented activities encompassing five main
studies that will be conducted during the inter-epidemic periods.
Starting date
February 1, 2014
Duration
5 years
Coordinator
University of Antwerp
Prof. dr. Herman Goossens
Budget
Funded by the European Commission’s FP7
Programme under grant number 602525
The European clinical research framework of PREPARE consists
of three interconnected platforms – PATHOS, PRACTICE and
PREDICT, supported by a common ICT infrastructure – CRISP
and strengthened by a comprehensive training and education
effort – CREATE (see picture at the right). Together they provide
the framework for rapid, harmonized, large-scale and fit-forpurpose clinical research in response to any severe ID outbreak
with a pandemic potential or significant risk of major damage to
health and socio-economics in the EU.
PREPARE has been designed to change the approach to
clinical research, so a next epidemic will not result in a missed
opportunity to save lives and advance medical knowledge.
Three large scale clinical research studies, PRACTICE Study A,
Study B and Study C, will be implemented with focus on specific
study objectives during inter-epidemic periods, and thereby
preparing the clinical research network of PREPARE for rapid
initiation of large scale clinical research in response to any major ID
outbreak that requires a European response.
European
platform for
patient
oriented
PATHOgenesis
Studies
Platform for
Harmonised and
Rapid response
Clinical Trials
in Infectious
diseases
in Children
and adults
in Europe
PREDICT
Because of this, clinical research studies generally miss the
initial waves of an epidemic or pandemic and in many cases
fail to enroll significant numbers of patients across the clinical
spectrum of disease, even during subsequent waves. This
in turn means the opportunity is missed to improve patient
outcomes and develop high-quality evidence to inform future
clinical management strategies at the ‘coalface’. Indeed,
in almost all epidemics over the last decades very little
research directly aimed at improving clinical management or
understanding pathogenesis has been able to be conducted.
PRACTICE
We currently do not have European framework for ensuring that
clinical research is built into epidemic responses and in fact
our present research culture often precludes a rapid clinical
response.
The EARL study is aimed at identifying and implementing
solutions to key structural (ethical, administrative, regulatory and
logistical (EARL) bottlenecks as well as behavioural and cultural
barriers to the rapid implementation of large multi-site clinical
studies in Europe in response to severe ID outbreaks.
The PRIME study is aimed at mapping the pan-European clinical
management of severe IDs and developing harmonised clinical
case definitions, guidelines and pre-approved protocols for large
multi-site clinical studies in Europe in response to severe ID
outbreaks.
PATHOS
PREPARE
European
Platform for
REsearch
and support on
Diagnostics for
Infectious
disease Clinical
Trials
CRISP: Clinical Research Information Sharing Platform
CREATE: Clinical Research Education And Training in Europe
At the core of PRACTICE are large pan-European clinical
networks of primary care, hospital care and intensive care.
European Community care and Hospital care networks
PATHOS
is PREPARE’s flexible multidisciplinary platform for
the rapid deployment of European harmonised large
scale patient-oriented PATHOgenesis research Studies
in response to severe ID outbreaks using a systems
medicine approach.
PREDICT will establish and maintain a European diagnostic
and typing platform to provide state-of-the-art
diagnostics for the clinical studies under PREPARE,
initiated in response to any severe ID outbreak.
CRISP
provides the PREPARE network with a common,
robust, reliable and GCP compliant data management
IT infrastructure enabling the rapid collection,
controlling, reporting and exchange of clinical
research data in PRACTICE, PATHOS and PREDICT.
CREATE In close collaboration with large European societies,
PREPARE will develop and implement CREATE, a
unique on-line open-access education and training
programme for hospital and primary care specialists,
aimed at empowering or ensuring the incorporation
of the clinical research and the results thereof into
optimized clinical practice, in the response to severe
ID outbreaks.
PREPARE
Platform for European Preparedness
Against (Re-)emerging Epidemics
CONTACTS
Coordinator
Herman Goossens
Vaccine & Infectious Disease Institute
University of Antwerp
Universiteitsplein 1
B-2610 Antwerp, Belgium
[email protected]
Tel.+32 3 821 3789
Deputy Coordinator
Menno de Jong
Academic Medical Center
[email protected]
Tel. +31 20 5665780
Project Manager
Frank Deege
Erasmus Medical Center
[email protected]
Tel. +31 10 7044077
PREPARE PARTNERS
University of Antwerp
VAXINFECTIO, Laboratory of Medical
Microbiology - Antwerp, Belgium
Academic Medical Center
Department of Medical Microbiology
Amsterdam, The Netherlands
University of Cardiff
Primary Care & Public
Health
Cardiff, United Kingdom
University Medical Center
Utrecht
Julius Centre, Department
of Medical Microbiology
Utrecht, The Netherlands
European Society of Intensive Care
Medicine - Brussels, Belgium
Communication Manager
Inge Dierynck
Vaccine & Infectious Disease Institute
University of Antwerp
[email protected]
Tel. +32 3 265 2586
For further information, please visit our website
www.prepare-europe.eu
Erasmus Medical Center
Department of Viroscience
Rotterdam, The Netherlands
Imperial College London
National Heart & Lung Institute,
Centre for Respiratory Infection
London, United Kingdom
University of Oxford
Clinical Research Unit
Oxford, United Kingdom
CAPNETZ Stiftung
Hannover, Germany
SERGAS-Hospital Clinico Universitario
de Santiago Pediatrics Department
Santiago de Compostela, Spain
HLA et Médecine
EISBM
Lyon, France
Insitut Pasteur
Molecular Genetics of RNA Viruses
Unit - Paris, France
Biocartis
Mechelen, Belgium
Biomax Informatics AG
Knowledge Management and Data
Mining - Planegg, Germany
Janssen Diagnostics
Beerse, Belgium
BioMérieux - Microbiology R&D
La Balme Les Grottes, France
Universitätsklinikum Bonn
Institute of Virology
Bonn, Germany
University of Split
Dept. of Public Health,
Croatian Centre for Global
Health - Split, Croatia
Fondazione PENTA
Padova, Italy
University College Dublin
School of Medicine and
Medical Science
Dublin, Ireland
University of Western
Australia
School of Medicine and
Pharmacology
Crawley, Australia
ERS - European Respiratory Society
Lausanne, Switzerland
WONCA - World
Organization of National
Colleges, Academies and
Academic Associations
of General Practitioners/
Family Physicians
Copenhagen, Denmark
ESWI - European Scientific Working
group on Influenza
Laarne, Belgium
Royal Brompton & Harefield NHS
Foundation Trust
London, United Kingdom
European Society of Clinical
microbiology and Infectious Diseases
Basel, Switzerland
Berry Consultants
Texas, United States
PREPARE is funded by the European Union under Grant Agreement 602525