Securing the advancement of clinical research in the field of infectious diseases
Following the signing of the Grant Agreement by the European Commission (EC), ECRAID-Base has secured funding of 30 million euros and will commence March 1st 2021. ECRAID-Base is the core set of activities for ECRAID (the European Clinical Research Alliance for Infectious Diseases), which aspires to become the first of its kind, pan-European clinical research network for infectious diseases in Europe. Over the five-year duration of ECRAID-Base, ECRAID will evolve into a self-sustaining, not-for-profit organisation conducting clinical research for both public and private sponsors.
ECRAID-Base continues and expands on the activities of COMBACTE and PREPARE: thanks to the investments made by the EC and the Innovative Medicines Initiative (IMI) over the last seven years, the ECRAID clinical network will be able to conduct clinical research faster, easier, and more cost-effective. The clinical research network of ECRAID encompasses over 2.000 sites in more than 40 European countries. It includes primary care settings (general practitioners), hospital settings (emergency rooms and intensive care units), paediatric care settings, clinical laboratories and long-term care facilities.
At the heart of ECRAID-Base are six perpetual clinical studies. All will mature towards adaptive platform trials, with capability to rapidly respond to public health threats. One of the studies is REMAP-CAP – for patients with pneumonia in ICU – that rapidly adapted to COVID-19. Within months the number of study sites was extended from 51 to 296. The study currently evaluates 31 interventions, has enrolled >5000 patients and delivered six treatment conclusions with immediate relevance for patient care.
Professor Marc Bonten, coordinator of ECRAID-Base and COMBACTE, says: “ECRAID will strengthen alliances with academic partners, the private sector and international organisations involved in infectious disease interventions to boost investments into protecting European public health. Our vision is to efficiently generate rigorous evidence to improve the diagnosis, prevention and treatment of infections. ECRAID will be an essential component of the Pandemic Preparedness strategy in Europe.”
Professor Herman Goossens, co-coordinator of ECRAID-Base and coordinator of PREPARE and RECOVER, adds: “In the absence of a sustainable European clinical research infrastructure, each new clinical study has to be designed and initiated from scratch, reinventing the wheel at almost every turn. After the study, the one-off network of hospitals or GPs is dismantled. Hence, study progress is usually slow, and study completion generally takes far longer than initially estimated. Having an existing network is fundamental to increase efficiency of clinical research and to rapidly respond to Infectious Diseases outbreaks.”
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PREPARE, the Platform for European Preparedness Against (Re-)emerging Epidemics, is an 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. ‘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. PREPARE is coordinated at the University of Antwerp. PREPARE is funded by the European Commission’s FP7 Programme under grant agreement No. 602525.
COMBACTE – Combatting Bacterial Resistance in Europe – was created to meet the challenges of clinical development of antibacterials in response to the worldwide growing problem of antibiotic resistance. This Innovative Medicines Initiative (IMI) program represents an unprecedented partnership between industry, academia and biotech organizations to combat antibiotic resistance in Europe by tackling the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. In collaboration with other consortia within IMI’s New Drugs 4 Bad Bugs (ND4BB) program, the COMBACTE projects will enable more rapid and efficient development and commercialization of much-needed new antibacterial treatments and diagnostic tests. COMBACTE is coordinated at UMC Utrecht.
This research project receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement No. 115523 | 115620 | 115737 | 777362 resources of which are composed of financial contribution from the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution.