on Infectious Diseases Infectious diseases continue to pose a serious threat to global health and economies Longterm sustained and coordinated efforts are needed to develop and implement a wide range of therapeutic preventive and diagnostic interventions to ID: 1045108
Download Presentation The PPT/PDF document "The European Clinical Research Alliance" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. The European Clinical Research Alliance on Infectious Diseases
2. Infectious diseases continue to pose a serious threat to global health and economies. Long-term, sustained and coordinated efforts are needed to develop and implement a wide range of therapeutic, preventive and diagnostic interventions to limit the impact of infectious diseases.
3. Purpose and missionEcraid stands for European Clinical Research Alliance on Infectious Diseases.Our purpose is to reduce the impact of infectious diseases on individual and population health.Our mission is to join forces and collaborate to efficiently deliver high impact studies.
4. COMBACTE — Combatting Bacterial Resistance in Europe — is an Innovative Medicines Initiative funded project focusing on improving the clinical development of antibacterial treatment programmes. The result is a comprehensive clinical research infrastructure consisting of four high-quality networks:PREPARE — Platform for European Preparedness Against (Re-)emerging Epidemics — is a large-scale European network funded by the Framework Programme 7 aimed at building operational readiness for rapid deployment of harmonised European clinical studies for any infectious disease outbreak. Ecraid is the long-term successor of COMBACTE and PREPARE
5. First of its kind clinical research networkfor infectious diseases in Europe
6.
7.
8. Ecraid is the first network of its kind to offer a single point of access to a pan-European‘warm-base’ clinical research network for infectious diseases. Through this, Ecraid offers significant competitive advantages over fragmented, isolated and ad-hoc clinical research networks.
9. Clinical research on infectious diseases in EuropeEcraid is oriented along three dimensions: geographical, clinical research settings and infectious diseases.Ecraid is a European clinical research network that includes countries on the WHO’s European list. Ecraid focuses on a broad range of infectious diseases caused by viruses, bacteria, fungi and protozoa that are of public health interest to Europe.Ecraid covers clinical research across all care settings including primary care, hospitals, paediatric care, long-term care facilities and laboratories. Ecraid’s European clinical research network is globally connected and can facilitate access to clinical sites and patients from clinical research networks outside Europe.
10. A warm-base research networkEcraid offers access to a warm-base pan-European clinical research network, experienced in delivering rapid, cost-efficient and high-quality clinical research.
11. CLIN-NetPrimary care network: >250 primary care sites in 20 European countriesHospital care network: >1,200 hospital sites in 42 European countriesPaediatric network: 90 paediatric sites in 18 European countriesLong-term care facility network: 14,000 beds in 11 European countries and IsraelOur network of clinics and hospitals can quickly and reliably recruit, monitor and report data in multinational, multi-centre trials at all clinical drug development stages.
12. LAB-Net, EPI-Net & STAT-NetLAB-Net includes over 900 laboratories in 42 European countries and has links with more than 300 labs in 33 countries outside of Europe.For bio-banking services related to viruses, Ecraid will make use of the well-established EU-funded European Virus Archive network that mobilizes a global network of 38 laboratories including 16 EU member state institutions and 9 non-EU institutions.EPI-Net is network of experts in epidemiology of infectious diseases.STAT-Net network of expert ID statisticians in the design of clinical studies and statistical methods and analyses.
13.
14.
15. Our servicesEcraid covers a full range of clinical studies on infectious diseases:Types of studiesResearch typesTrial phasesSponsorsObservational | InterventionalPrevention | Treatment | Diagnostic | Screening | Epidemiological Quality of life | Health EconomicsPhase I | Phase II | Phase III | Phase IVInvestigator-initiated (non-commercial) | Industry-initiated (commercial)
16. Our modular menu of servicesDATA MANAGEMENTBIO-BANKINGTRAINING AND PUBLIC ENGAGEMENTSERVICE COMPONENTClinical study, clinical and lab database, and data management planBio-banking samples and strainsTraining and materials for clinical sites and labsPatient and public contributor input
17. Our modular menu of servicesFor each service component, one of four options can be selected:Design/Execute: Ecraid will take on the full responsibility of performing the specific service component, e.g., site selection.Co-Design/co-Execute: Ecraid will collaborate with the client/third-party service provider (selected by the client) to execute the tasks, e.g. site monitoring.Review/Advise: Ecraid will review/advise on the tasks performed by the client/third-party service provider, e.g. reviewing a clinical trial protocol. No service required: This option may be selected in cases where the client has sufficient expertise in-house or has established good working relationships with third-party service providers that it wishes to make use of.
18. Innovative design elements in clinicalstudiesBy applying combinations of the six design elements below, Ecraid will build up a portfolio of investigator and/or industry initiated clinical research studies using Ecraid’s warm-base network. Continuous enrolment Shared control group Response adaptive randomisation Master protocol Nested trial Platform design
19.
20.
21. Higher quality trials, reduced time, reduced costsEcraid’s warm-base clinical research network enables us to help reduce the time needed to complete a study. Ecraid’s key performance metrics contributes to cost-efficiencies:STUDY START-UP TIMEENROLMENT RATEPERFORMANCE RELIABILITYSTUDY COMPLETIONAMENDMENTSRESOLUTION OF ISSUESRESPONSIBLE COMMUNICATIONKEY PERFORMANCE METRICS
22. Higher quality trials, reduced time, reduced costsSHORTER STUDY START-UP TIMEEcraid can shorten the time to a finished protocol thanks to its sustained institutional experience and expertise on study specifics, its repository of previously developed protocols, in-house expertise, and a network with local expertise.ENROLMENT RATEEcraid is better positioned to enrol patients with a short window of opportunity and to meet enrolment targets thanks to its large European network: numerous clinical sites with an “institutional memory”, a large warm-base network, knowledge of the sites and their patient populations, established working relationships and contracts.FASTER STUDY COMPLETIONClear monitoring and safety processes thanks to a high-quality study protocol.Faster data cleaning processes due to a high-quality study protocol. Consistent, high-quality and validated data inputs from the labs as a result of the collaboration with experienced labs.
23. PERFORMANCE RELIABILITYEcraid will limit discrepancies between actual vs. planned study conduct with reliable start-up times and enrolment predictions per country and per site. This is a result of our knowledge and the relationships built with network sites accumulated over years of collaboration on various clinical studies.AMENDMENTSEcraid will reduce the number of protocol amendments to a minimum thanks to high-quality study protocols co-designed by key European experts on clinical research on infectious diseases across Europe.RESOLUTION OF ISSUESEcraid will swiftly resolve any issues during the study, with a minimum impact on quality, cost and time thanks to longstanding professional relationships with network sites and their PIs.RESPONSIBLE COMMUNICATIONEcraid has effective direct lines of communication with the clinical sites, which is necessary for professional and efficient trial execution, and is a result of our already established and trusted relationships.Higher quality trials, reduced time, reduced costs
24.
25. Introducing cost-efficienciesLargely dependent on the size, type and complexity of the clinical study, cost-efficiencies can be gained by:More efficient trial designs that reduces the number of patients needed for completing a clinical studyPerformance-based site selection that leads to more reliable inclusion predictionsEfficient site contracting with master contracts in place for key sites across European countriesFaster completion of clinical studiesCost-savings thanks to high-quality protocols that limit the risk of amendments
26. Outbreak preparedness‘Inter-epidemic’ modeThe Ecraid network infrastructure is operationally prepared to rapidly initiate a clinical research response addressing key questions in the event of an infectious disease outbreak. Perpetual Observational Studies (POS) are designed to account for the need of the network to be flexible and responsive to multiple scenarios. The REMAP-CAP adaptive platform study, which focuses on hospital settings, was ready to include COVID-19 patients within 38 days after WHO declared COVID-19 a Public Health Emergency of International Concern.ECRAID-Prime will be the first-of-its-kind European Adaptive Platform Trial on COVID-19 and COVID-like illness therapeutics in the community setting, designed as a counterpart to REMAP-CAP.Training activities conducted in Ecraid’s warm-base network will include simulation training and preparedness exercises to deliver a research response in the event of a widespread ID threat.Ecraid’s warm-base clinical research network can function as a platform for a coordinated European clinical research response to ID outbreaks. It provides organisational infrastructure and processes to achieve the desired coordination across studies without compromising the need to rapidly initiate studies thanks to the OPERATES requirements.
27.
28. GovernanceEcraid has been established as a not-for-profit foundation under Dutch Law. The foundation employs the management board and central support staff of Ecraid. The Ecraid Management Board is responsible for the overall coordination and management of Ecraid. This board is supervised by a Supervisory Board.Marc BontenChief Executive OfficerMANAGEMENT BOARDEvelina TacconelliChief Scientific OfficerNils VisserChief Operations OfficerFrank DeegeHerman GoossensSTRATEGIC ALLIANCES
29. Coordinating CommitteeThe Ecraid Coordinating Committee functions as the central body in Ecraid and is responsible for the European-wide coordination of clinical studies on infectious diseases, strategy development, stakeholder management and service and network development.Marion KoopmansOutbreak Preparedness and ResponseDisease-X POSVEOLennie DerdeREMAP-CAP Adaptive PlatformTrialPeter HorbyPOS on ARI in ERMERMAIDS 2.0Christopher ButlerPOS on ARI in Primary CareSOS-COVID, PRUDENCE,ECRAID-PrimeJesús Rodriguez BañoPOS on cUTI in ERsBruno FrançoisPOS on VAP in ICUsYazdan YazdanpanahEU-RESPONSEOliver CornelyVACCELERATEMarc BontenChairCOMBACTE and CLIN-Net, CEO EcraidEvelina TacconelliEPI-Net, LOTTA-Net,ORCHESTRACSO EcraidStephan HarbarthSTAT-NetJacques Demotes-MainardECRINData ManagementThomas JaenischRECODIDData SharingSibyl AnthierensPublic EngagementJean-Louis RometteEuropean Virus Archive (EVA-g)Herman GoossensLAB-NetArjana Tambić AndraševićCapacity Building Eastern EuropeCarlo GiaquintoPENTA-IDVERDI
30. 30Frank Møller Aarestrup Technical University of DenmarkAntonino Di Caro Unicamillus International University of Medicine RomeHervé Raoul INSERMSeamus O’Brien Global Antibiotic Research and Development PartnershipMarco Cavaleri European Medicines AgencyNina GobatUniversity of OxfordNicole Lurie Coalition for Epidemic Preparedness InnovationsDavid PatersonUniversity of Queensland,ADVANCE-IDMarc MendelsonUniversity of Cape TownRobert WeinsteinRush University, ChicagoXavier De Lamballerie Aix Marseille UniversityVance FowlerDuke University, Antibiotic Resistance Leadership GroupGuy ThwaitesOxford University Clinical Research UnitScientific Advisory BoardThe Ecraid Scientific Advisory Board provides the Coordinating Committee with expert advice and feedback on its services, network composition, innovative trial designs and technologies and ethics, etc. Evelina TacconelliChairCSO Ecraid
31. Our locationsThe Management Board, the central operational service and support units are located at Ecraid HQ in Utrecht, Netherlands. Ecraid Chief Offices (ECHOs) have been established where key operational service, network and study coordinating units are located, which are headed by the respective Coordinators of the Coordinating Committee.
32.