• Workpackages

Workpackages

Workpackage 1
EARL: Ethical, Administrative, Regulatory and Logistical solutions

The EARL study is aimed at identifying and implementing solutions to key structural (ethical, administrative, regulatory and logistical) bottlenecks as well as behavioural and cultural (BC) barriers to the rapid implementation of large multi-site clinical studies in Europe in response to severe ID outbreaks.

 
 
Workpackage 2
PRIME: clinical PRotocols and guidelines for Id Management in Europe

The PRIME study is the clinical counterpart of the EARL study and it aims at mapping the pan-European clinical management of severe IDs and develop harmonised clinical case definitions, guidelines and pre-approved protocols for large multi-site clinical studies in Europe in response to severe ID outbreaks.

Workpackage 3
PRACTICE A: Observational study

European Multi-centre standardised observational and natural history clinical data study in hospitalised and community patients (children and adults) with acute respiratory infection, severe illness caused by central nervous system infections, diarrhoea, or hemorrhagic fever.

Workpackage 4
PRACTICE B: Interventional Trial ILI in Primary Car

European Multi-centre open, adaptive, randomised interventional trial on Influenza-Like-Illness (ILI) in Primary Care (PC).

 
 
Workpackage 5
PRACTICE C: Adaptive randomised trial SARI

European adaptive randomised controlled trial to improve survival in hospitalised patients with Severe Acute Respiratory Infection (SARI).

Workpackage 6
PATHOS: European harmonised large scale patient-oriented PATHOgenesis research Studies in response to severe ID outbreaks

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. PATHOS is aimed at identifying the relative contributions of host- and pathogen factors to development of severe disease across different aetiologies, ages and clinical backgrounds. Such pathophysiological insights are central to development of effective clinical management strategies during severe ID outbreaks.

Workpackage 7
PREDICT: European harmonised large scale patient-oriented PATHOgenesis research Studies in response to severe ID outbreaks

European Diagnostic Platform for REsearch and support on Diagnostics for Infectious disease Clinical Trails.

Workpackage 8
Clinical Research Information Sharing Platform

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. CRISP is based on the well-tried Research Online System, that supported data entry, storage and analysis for large scale clinical research studies in several other European FP6 and FP7 funded networks (e.g., GRACE, MOSAR, OPTIMISE, R-GNOSIS).

Workpackage 9
CREATE: Clinical Research Education And Training in Europe

A unique on-line open access and face-to-face education and training curriculum that comprehensively addresses the issues relevant to empower or ensure the incorporation of laboratory and clinical research and the results thereof, in the response to emerging epidemics.


Why PREPARE?

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 infectious disease is extremely challenging and often delayed. We currently have no European framework for ensuring 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 enrol 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. These experiences have demonstrated that unless something is done now to change the approach to clinical research, the next epidemic will result in a similar missed opportunity to save lives and advance medical knowledge. PREPARE has been designed to address this problem.