Creation of a European wide sustainable clinical research network for infectious diseases

Proposals should build on successful European collaborative initiatives such as PREPARE[[https://www.prepare-europe.eu/]] and COMBACTE[[https://www.combacte.com/]] and further advance clinical research in the field of infectious disease by supporting the establishment of a European wide multidisciplinary clinical research network. Such a network should be capable of performing all clinical trial aspects encompassing study design, execution and reporting (sex and gender differences analysis to be included where relevant). It should develop and allow for innovative research approaches and enable flexibility in responding to unpredictable events and signals. The network should provide clear and direct access for stakeholders including academic organizations, SMEs and larger industry to perform clinical studies. The proposal should develop a business plan to ensure the sustainability of the network. The network should actively disseminate information and contribute to awareness rising. Furthermore, it should also create synergies with global initiatives, enabling quick and smooth interactions and collaboration across the world.

The Commission considers that a proposal requesting an EU contribution between EUR 2 to 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amount.

Infectious diseases pose a serious threat to global health. Emerging epidemics, pandemics and rising levels of antimicrobial resistance require a strong and coordinated response to protect citizens in Europe and beyond as indicated in the European One-Health Action Plan against AMR. There is a need to establish a clinical research network across Europe that has the capacity and capability to directly enrol patients with infectious diseases, to increase efficiency for testing and developing new diagnostic, preventive and/or therapeutic strategies and therapies. This should allow generating rigorous evidence to improve the diagnosis, prevention and treatment of infections and to better respond to infectious disease threats, and 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 in cooperation with the existing global experts networks and infrastructures such as ECRIN[[http://www.ecrin.org/]] to ensure the common benefit of the outcomes[[http://www.mhlw.go.jp/seisakunitsuite/bunya/hokabunya/kokusai/g7kobe/KobeCommunique_en.pdf]].

• Reduce the cost and time of clinical trials for diagnosis, prevention and treatment of infections.
• Attract industry back to invest in the development of anti-infectives.
• Strengthen the operational capacity and the required infrastructures for clinical research.
• Increase information exchange between sectors and scientific disciplines.
• Maintain Europe's leading role in combating AMR and controlling infectious diseases.
• Ensure global collaboration between networks in Europe and other countries/regions to optimise a coordinated response to infectious diseases.