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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