Few health issues threaten human existence to the extent of infectious disease and antimicrobial resistance. These global health threats require global action, and a new EU clinical research alliance is uniting the research efforts of several countries to find ways of tackling them. Dr Nina Gobat, Senior Researcher, describes how the EU-funded PREPARE trial, led in the Nuffield Department of Primary Care Health Sciences, is laying the foundation work for this new alliance.
(Re-)emerging infectious diseases and the rise of antimicrobial resistance (AMR) present an ongoing and serious threat to the health, wellbeing and prosperity of individuals and societies worldwide. The estimated annual cost of pandemics is $60 billion and effective diagnostics, drugs and vaccines are lacking for many emerging infectious disease threats.
While many of these emerging infectious diseases are viral in origin, bacterial infections are also becoming increasingly untreatable, due to AMR. This global emergence of AMR coincides with a marked fall-off in the development of novel antibiotics and sub-optimal use of existing antibiotics.
Tackling these global challenges requires multi-country co-operation and co-ordination.
Across the European Union, initiatives have been funded over many years to develop the infrastructure and expertise to deliver multi-site, pan-European clinical research with the capability to respond to these public health threats. However, clinical research initiatives are usually funded exclusively as projects, with time-limited contracts and defined scopes. If the capability and infrastructures built through project-based clinical research initiatives are not maintained, the return on these major EU investments will be dramatically curtailed.
Tackling these global challenges requires multi-country co-operation and co-ordination. Across the European Union, initiatives have been funded over many years to develop the infrastructure and expertise to deliver multi-site, pan-European clinical research with capability to respond to these public health threats.
The European Clinical Research Alliance for Infectious Diseases (ECRAID) represents a bold and ambitious vision: a financially self-sustaining clinical research network perpetually delivering high-quality clinical research aimed at combatting emerging infectious diseases and antimicrobial resistance.
ECRAID-Plan is a two-year project (January 2019 - Dec 2020) that will develop the business plan for ECRAID. Funded by the European Commission’s H2020 programme (grant number 825715), ECRAID-Plan is developing the scope, services, operations, governance and business model for ECRAID.
ECRAID’s mission is to reduce the impact of infectious diseases on individual and population health by efficiently generating rigorous evidence to improve the diagnosis, prevention and treatment, and to better respond to threats from infectious diseases.
The ECRAID vision
ECRAID is an initiative of two pan-European projects with key roles in the combat of EID and AMR:
PREPARE, coordinated by Prof. Herman Goossens of the University of Antwerpen
COMBACTE, coordinated by Prof. Marc Bonten of UMC Utrecht. From the University of Oxford, Prof. Chris Butler (Nuffield Department of Primary Care Health Sciences) leads the PREPARE primary care clinical trial, ALIC4E, and Prof. Peter Horby leads MERMAIDS, a suite of observational studies for PREPARE.
Together, PREPARE and COMBACTE represent over 300 million Euros of EU and private sector investments in clinical research infrastructure for infectious diseases (ID).
COMBACTE is active in 42 European countries... more than 10,000 patients have been enrolled.
In common with many networks PREPARE and COMBACTE are currently funded exclusively through project-based funding and the existing grant agreements come to an end in 2021. The logical step in the development of PREPARE and COMBACTE is that they evolve from a public and private funded, project-based, ad-hoc research collaboration, into an integrated, sustainable, single-point-of-access, coordinated pan-European clinical research network, with appropriate governance and legal structures.
This new organisation should generate complementary sustainable sources of income, ensuring the long-term continuity of its activities and produce rigorous, innovative, world-leading research that helps provide long-term protection from infectious diseases to EU citizens.
The Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) is a large scale European network, including 27 beneficiaries and is funded by the EU FP7 Programme.
PREPARE started its activities in February 2014. PREPARE aims for the creation of operational readiness for rapid deployment of harmonised European clinical studies for any infectious disease and effective spread of evidence-based clinical guidelines via public health agencies to healthcare centres over the globe.
In addition, within PREPARE inter-epidemic research will be performed to study questions to allow for optimal clinical management of patients suffering with infectious diseases.
More than 5,000 patients have been enrolled in hospital and primary care sites.
COMBACTE (Combatting Bacterial Resistance in Europe) is part of the IMI funded programme ND4BB (New Drugs for Bad Bugs) and focuses on improving the clinical development of antibiotics. The goals are to create a self-sustaining antibacterial development network and to increase the efficiency of antimicrobial drug development.
To this purpose it has established an infrastructure consisting of four high-quality networks: CLIN-NET, LAB-NET, STAT-NET and EPI-NET.
COMBACTE is active in 42 European countries, with a total of 788 clinical sites and 543 laboratories.
To date, 17 trials are being managed, including phase I – III trials for 6 new compounds against multi-resistant bacteria. More than 250 different clinical study sites across Europe have enrolled more than 10,000 patients.
The European Commission has invested EUR3 million in ECRAID-Plan to develop the business plan for ECRAID by December 2020.
ECRAID’s business plan will
- detail the scope, services, operations, governance, financial and business model for ECRAID and will attract start-up investment for ECRAID operations.
- set out a strategy that aligns with the mandates, activities and ambitions of other relevant organisations, including European public health and pre-clinical networks and international clinical research networks. These networks are strategic partners in ECRAID-Plan.
- build awareness and create support for ECRAID among a broad group of stakeholders.
How will the ECRAID-Plan work?
ECRAID-Plan starts with a detailed stakeholder analysis conducted together with consultants from Monitor Deloitte, including (a) an “inside-out” gap-analysis of resources, capabilities and infrastructures of PREPARE and COMBACTE, the legacy networks of ECRAID, and (b) an “outside-in” analysis of external stakeholder needs and wants from ECRAID together with analysis of the scientific, technological, commercial, economic, political and societal environment that ECRAID will operate in.
The outcome of the stakeholder analyses (May 2019) will inform the development of services and operations alongside the governance and financial modelling.
- involves direct involvement of relevant EU funded projects, networks and organisations. These strategic partners meet regularly during face-to-face workshops to feed into iterations of the plan.
- involves a multi-actor approach that engages key stakeholder groups in the health system, including industry partners, patient groups, regulators, policy makers, professional societies, healthcare providers and funders.
ECRAID-Plan was launched at a high-level kick off meeting in January 2019, Brussels.
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