New therapies for chronic diseases Proposals should focus on clinical trial(s), supporting proof of concept of clinical safety and efficacy in humans[[Phase 3 and phase 4 clinical trials are excluded.]] of novel therapies (pharmacological as well as non-pharmacological) or the optimisation of available therapies (e.g. repurposing) for chronic non-communicable or chronic infectious diseases. Preclinical research should be completed before the start of the project. Proposals should provide a sound feasibility assessment, justified by available publications or provided preliminary results. Gender and age must be considered whenever relevant. Due consideration should also be paid to involve patients and take their views into account wherever relevant. Rare diseases and regenerative medicine are not within the scope of this topic[[See topic SC1-PM-08-2017 addressing new therapies for rare diseases.]],[[See topic SC1-PM-11-2016-2017 addressing clinical research on regenerative medicine]].The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Chronic diseases represent a significant burden on individuals and healthcare systems in the European Union and beyond. Innovative and effective therapeutic approaches are required to provide the best quality of care when prevention strategies fail. While considerable basic knowledge has been generated by biomedical research in recent years, the development of new therapies is stagnating, in part due to a lack of clinical validation. New or optimised therapeutic strategies, adapted where relevant to the different needs of men, women, children and the elderly, with the highest potential to generate advances in clinical practice and care for chronic non-communicable or chronic infectious diseases. Improve the therapeutic outcome of major chronic health issues with significant impact on disease burden of individual patients and health care systems.