European Community care and Hospital care networks

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.

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-for-purpose 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.

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.

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.

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.

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.

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.

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.

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.

At the core of PRACTICE are large pan-European clinical networks of primary care, hospital care and intensive care.

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.

PREPARE

WHY PREPARE PREPARE Platforms

PATH

OS

PRAC

TICE

PRED

ICTEuropean

platform forpatient

orientedPATHOgenesis

Studies

EuropeanPlatform for

REsearchand support onDiagnostics for

Infectiousdisease Clinical

Trials

Platform forHarmonised andRapid response

Clinical Trialsin Infectious

diseasesin Children and adultsin Europe

CRISP: Clinical Research Information Sharing Platform

CREATE: Clinical Research Education And Training in Europe

PREPARE is funded by the European Union under Grant Agreement 602525

PREPARE

Platform for European Preparedness Against (Re-)emerging Epidemics

Coordinator Herman GoossensVaccine & Infectious Disease InstituteUniversity of AntwerpUniversiteitsplein 1B-2610 Antwerp, Belgiumherman.goossens@uza.beTel.+32 3 821 3789

Deputy Coordinator Menno de JongAcademic Medical Centerm.d.dejong@amc.uva.nlTel. +31 20 5665780

Project Manager Frank DeegeErasmus Medical Centerf.deege@erasmusmc.nlTel. +31 10 7044077

Communication Manager Inge DierynckVaccine & Infectious Disease InstituteUniversity of AntwerpInge.Dierynck@uantwerpen.beTel. +32 3 265 2586

CONTACTS PREPARE PARTNERS

For further information, please visit our websitewww.prepare-europe.eu

University of AntwerpVAXINFECTIO, Laboratory of Medical Microbiology Antwerp, Belgium

Academic Medical CenterDepartment of Medical MicrobiologyAmsterdam, The Netherlands

University of CardiffPrimary Care & Public HealthCardiff, United Kingdom

University Medical Center UtrechtJulius Centre, Department of Medical Microbiology Utrecht, The Netherlands

European Society of Intensive Care MedicineBrussels, Belgium

Erasmus Medical CenterDepartment of ViroscienceRotterdam, The Netherlands

Imperial College LondonNational Heart & Lung Institute, Centre for Respiratory InfectionLondon, United Kingdom

University of OxfordClinical Research UnitOxford, United Kingdom

CAPNETZ StiftungHannover, Germany

SERGAS-Hospital Clinico Universitario de Santiago Pediatrics DepartmentSantiago de Compostela, Spain

HLA et MédecineEISBMLyon, France

Insitut PasteurMolecular Genetics of RNA Viruses UnitParis, France

University of SplitDept. of Public Health, Croatian Centre for Global HealthSplit, Croatia

University College DublinSchool of Medicine and Medical ScienceDublin, Ireland

BiocartisMechelen, Belgium

Biomax Informatics AGKnowledge Management and Data MiningPlanegg, Germany

Janssen DiagnosticsBeerse, Belgium

BioMérieuxMicrobiology R&DLa Balme Les Grottes, France

Universitätsklinikum BonnInstitute of VirologyBonn, Germany

Fondazione PENTA Padova, Italy

University of Western AustraliaSchool of Medicine and PharmacologyCrawley, Australia