Creation of a European wide sustainable network for harmonised large-scale clinical research studies for infectious diseases

Deadline: Apr 7, 2020  
CALL EXPIRED

Infectious diseases pose a serious threat to human health and there are many challenges and needs to efficiently protect citizens across Europe and beyond. There is still a need to understand how antibiotics and other interventions work on patients and how to better assess the effectiveness of vaccines. Innovation is needed to overcome the problem of antimicrobial resistance, and in case of emerging epidemics and pandemics, a timely response to a rapidly emerging infectious diseases is significantly challenging and often delayed. In this context there is a need to establish a pan-European clinical research network that has the capacity and capability to directly enrol patients with infectious diseases, and to increase efficiency for testing and developing new diagnostic, preventive and/or therapeutic strategies and therapies. Europe should also contribute to the G7 aim concerning the need to establish a global clinical studies network on drug resistance that provides access to a large clinical research infrastructure for the design, coordination and conducting of clinical trials and studies. It should also respond to the Council Recommendation on strengthened cooperation against vaccine preventable diseases^[1], which calls for the reinforcement and establishment of novel infrastructures to increase the effectiveness and efficiency of EU and national vaccine R&D funding.

Proposals should set up a European-wide multidisciplinary network able to provide a platform for a rapid response in the conduct of clinical studies in relation to any severe infection. The initial clinical studies to be performed should be included in the proposal, whereas criteria and processes for including further clinical studies in the project should be clearly described. This should include provisions for flexibility (including re-allocation of budget and de-prioritisation) in case of new scientific developments and in particular the need to address newly or re-emerging infectious diseases.

The proposed consortium should comprise expertise of stakeholders from academic organizations, SMEs, larger industry, patient organisations, ethics committees, public health bodies and regulators. It is expected to perform clinical studies and further advance clinical research in the field of infectious diseases. It should develop new, or make use of existing, standardised methodological approaches to rapidly perform large-scale clinical trials with the view of delivering optimal diagnosis and preventive or therapeutic interventions to patients affected by infectious diseases, taking into account sex and gender differences when relevant. Applicants should build on the results of successful European collaborative initiatives such as PREPARE^[2] and COMBACTE^[3]. Proposals should build on established structures for infectious disease clinical research at national or regional scales. To ensure the common benefit of the outcomes, it should also work in cooperation with existing global experts networks and infrastructures such as ECRIN^[4]and BBMRI^[5]. Proposals should in particular take into account the available result of the H2020-funded project ECRAID Plan (project resulting from SC1-HCO-08-2018). The network should address all aspects of clinical trial conduct, from study preparation and design, trial management and reporting. It should develop and allow for innovative research approaches and enable flexibility in responding to unpredictable events during its implementation. The sustainability of the network should be carefully worked out in the proposal. Furthermore, the network should create synergies with global initiatives, enabling quick and smooth interactions and collaboration across the world.

Special attention should be given to EU Member States and Associated Countries with currently limited capacity to perform clinical trials.

The Commission considers that a proposal requesting an EU contribution between EUR 25 to 30 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amount.

• Reduced cost and time through efficiently implemented clinical trials for diagnosis, prevention and treatment of infections.
• Create and strengthen the operational capacity and the infrastructures for providing real-time evidence for optimal medical intervention and practice in infectious diseases.
• Contribute to existing EU policies, including the Council Recommendation on strengthen cooperation for vaccine preventable diseases, and the Communication "A European one health action plan against Antimicrobial Resistance (AMR)”^[6].
• To ensure the EU´s worldwide leadership in controlling and responding to infectious diseases.
• Foster links between existing networks in Europe and other countries/regions in the world to optimise a coordinated response to infectious diseases for innovation and delivery of new preventive and therapeutic technologies.
• Foster collaboration between stakeholders from academic organizations, SMEs, larger industry, patient organisations, ethics committee, public health bodies and regulators.

International cooperation
Gender

[1]http://data.consilium.europa.eu/doc/document/ST-14152-2018-REV-1/en/pdf

[2]http://www.prepare-europe.eu/

[3]https://www.combacte.com/

[4]http://www.ecrin.org/

[5]http://www.bbmri-eric.eu/

[6]https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf