Innovative healthcare interventions for non-communicable diseases

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Expected Outcome: This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes: Researchers, developers and clinical practitioners have access to state-of-the-art knowledge, data, technologies, tools, methods, best practices, and trainings to develop innovative healthcare interventions aimed at reducing burden of the following specific Non-Communicable Diseases (NCDs): cardiovascular diseases, diabetes, chronic respiratory diseases or chronic kidney diseases. Scientific and clinical communities can use innovative healthcare interventions to generate meaningful advances in clinical practice and care for patients with NCDs following validation in late-stage clinical trials. Scientific and clinical communities make wide use of relevant databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR[1] principles, thereby encouraging further use of the data. Policymakers, scientific and clinical communities, developers, patient organisations, regulators, and other relevant bodies are informed of the research advances made and the requirements for a widespread implementation of the innovative therapeutic interventions and complementary approaches. Patients and caregivers are constructively engaged with the research, ensuring that their needs are catered for, with the aim of tangibly benefitting from the interventions. Scope: NCDs represent over 80% of the disease burden in Europe and the leading cause of avoidable premature deaths. Innovative and effective healthcare interventions are required to provide treatment and disease management solutions and assure best quality of care for patients suffering from NCDs when prevention strategies have failed. Proposals should address all the following aspects: Perform rigorous early stage[2] clinical trial(s) to validate novel or refined healthcare interventions[3] for treatment and/or disease management solutions for patients suffering from the following specific NCDs: cardiovascular diseases, diabetes, chronic respiratory diseases or chronic kidney diseases[4]. Whenever relevant, existing co- and multimorbidities should be addressed in the trial design. Clinical trial(s) should be supported by completed proof-of-concept[5] of clinical safety and efficacy. Both preclinical research and the draft clinical trial protocol should be completed at the time of submission of the proposal. Proposals should also demonstrate evidence of preliminary consultations with ethics and regulatory authorities at the time of submission. A sound feasibility assessment, including an appropriate patient selection and realistic recruitment plans, justified by publications or preliminary results should be…