Prevention and management of chronic non-communicable diseases in children and young people (GACD)

Policymakers, public health managers and authorities, parents and their children, and young adults have access to evidence and recommendations for national programmes and policies to improve quality of life in children and/or young people and extend healthy life expectancy. Researchers, clinicians, policymakers, public health managers and authorities have an improved understanding how to effectively adapt and/or scale up interventions for prevention and management of chronic NCDs in children and/or young people at local, regional, and national levels. Communities, parents and their children, young adults, local stakeholders and authorities are fully engaged in implementing and taking up interventions that tackle NCDs in children and/or young people. Scope: The Commission is a member of the Global Alliance for Chronic Diseases (GACD) [2] . The GACD specifically addresses NCDs and supports implementation research [3] to improve health outcomes. This topic is launched in concertation with the other GACD members (international funding agencies) and aligned with the 12 th GACD call. Chronic NCDs that begin in childhood have an impact on both quality of life and life expectancy. Onset of many NCDs diseases occurs at younger ages in LMICs, and this is further accompanied by a longer duration of disease and a higher rate of complications, including multimorbidity. The conditions in which people are born, grow and live (the social determinants of health) including access to good nutrition, education, housing, and healthcare are major contributors to health and ill health [4] . Up to 70% of preventable adult deaths from NCDs are linked to risk factors originating in childhood and adolescence [5] , and interventions that can successfully control or prevent chronic disease in young people can dramatically improve health outcomes later in life. Childhood and adolescence are critical periods, when behaviours associated with NCD risk are adopted including tobacco use, alcohol use, substance abuse, unhealthy diets and sedentary lifestyles and children and young people are often targeted by commercial marketing of unhealthy products. The aim of this topic is to fund implementation research, exploring strategies, evidence-based program and policy interventions across prevention, diagnosis, screening and management of chronic NCDs, centred on the critical life stages spanning early childhood to young adulthood (1-24 years of age) living in LMICs, and/or underserved populations in HICs. In this regard, proposals focused on implementation research should explore implementation strategies on evidence-based interventions, adaptations of interventions and tailored interventions, or initiatives including (though not limited to) those focussed on one or more of the following: Policy evaluation to tackle childhood- and/or youth-relevant social, economic, political, structural or commercial determinants of chronic NCD conditions. Prevention of NCDs using children and/or young people targeted implementation strategies (e.g. educational strategies, vaccination strategies, promotion of behavioural and lifestyle changes). Screening and diagnosis of NCDs (or risk factors) in children and/or young people (in particular use of digital tools). Cost effective and patient-centred management of NCDs in children and/or young people (including access to medicines and equipment; integrated care pathways; continuity of care for adolescents with existing non-communicable diseases who "age out" of paediatrics, caregiver health and support, citizen science approaches). Multiple interventions focus on prevention of NCDs in children and young people, yet relatively few have focussed on strategies for management of chronic conditions in these critical life stages, and a limited number of studies have been carried out to study implementation of these in LMIC contexts or with underserved communities. In this instance it would be anticipated that proposals should explore implementation strategies using the appropriate hybrid design study incorporating effectiveness and implementation research outcomes. Therefore, it may be important to undertake formative research as a part of the proposal to support readiness for implementation. The proposed implementation research should be focused on one or more evidence-based interventions (or complex interventions), providing existing evidence of the intervention’s effectiveness, cost-effectiveness, sustainability, scalability and potential for long-term health and other impacts (and in what context this evidence has been generated). Applicants should provide rationale and explore the implementation of proposed intervention(s) for a selected study population(s) based in one or more LMICs, and/or underserved populations experiencing health disparities, including Indigenous populations, in HICs, considering the unique social, political, economic, and cultural context(s) in which the study will take place [6] . Applicants should justify why any adaptation will not compromise the known effectiveness of the selected intervention(s). Proposals should address all the following implementation research activities [7] : Clearly describe the implementation research methodology, including the statistical design. Have an appropriate strategy for measuring implementation research outcomes and real-world effectiveness outcomes and indicators. Specifically address issues of equitable implementation to ensure interventions reach the populations that need them the most. Engage an appropriately expert and skilled research team which can ensure a suitable multidisciplinary approach and that demonstrates equitable partnership and shared leadership between HIC-LMIC, and/or non-Indigenous-Indigenous members of the project team and external stakeholders through a clear governance strategy. Provide a stakeholder engagement strategy with evidence of support/engagement from key stakeholders for delivering the intervention and a pathway to sustain the proposed intervention (if proven effective) after the funding from the GACD grant ends. Provide opportunities for NCD-focused implementation research capacity building for early career researchers and team members from lower resourced environments, such as LMICs or disadvantaged communities. Ensure meaningful involvement of early career team members, including at least one early career member as a co-investigator. The study population may include children and/or young people in the general population, with one or more existing NCDs, those currently without NCDs, or a combination of any of the above. Applicants may propose implementation research focused on interventions that are implemented at the individual, family, community (e.g. work or school), population, and/or structural level. With regard to NCDs, applicants are encouraged to explore any chronic non-communicable condition (or combination of conditions), including mental health disorders, autoimmune conditions, musculoskeletal conditions, neurological disorders and sleep disorders and/or any risk factor (or combination of risk factors). Additionally, whenever relevant, applicants are also encouraged to take a life course approach, adapting interventions for particular life stages with the goal of promoting life-long health. Proposals should use an appropriate implementation research design and framework [8] , before and after studies, and additional implementation science classifications of study designs (e.g. hybrid designs [9] ), noting that applicants are not limited to any particular design. Proposals would be expected to generate evidence that is of direct relevance to policymakers, communities and practitioners. Proposed work should identify and engage all key stakeholders necessary and relevant to the development, undertaking and knowledge translation phases of the project, including meaningful collaboration with young people themselves (and their families). Proposals should also consider using co-development and co-design approaches, involving policymakers, local authorities, community groups, educators, healthcare providers, and other individuals or organisations necessary to the delivery and sustainability of the study outcomes. Project partners should be engaged from the beginning to contribute to the sustainability of the intervention after the end of project. Proposals should demonstrate sustainability of the strategy, beyond the lifespan of the project. Poverty, discrimination based on sex, racial or ethnic origin [10] , religion or belief, disability, age, and other inequities are directly associated with reduced potential for equitable access to quality care. Proposals should consider relevant determinants of health (e.g. social, structural, commercial, economic) and discuss their potential impact on the effective implementation of the intervention(s). If there is a focus on a particular population (e.g. gender, racial or ethnic origin [10] , etc.), then the reason for this should be justified. This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities. All projects funded under this topic are strongly encouraged to participate in networking and joint activities, including internationally, as appropriate. These activities could, for example, involve the participation in joint workshops, the Annual Scientific Meetings of the GACD, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for such activities and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. Applicants should provide details of their clinical studies [12] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged. [1] As defined by the World Bank, https://www.worldbank.org [2] https://www.gacd.org [3] https://iris.who.int/bitstream/handle/10665/91758/9789241506212_eng.pdf [4] https://www.taylorfrancis.com/chapters/oa-edit/10.4324/9781003306689-20/social-determinants-health-ncds-ruth-bell-jaime-miranda-jean-woo-michael-marmot [5] https://data.unicef.org/topic/child-health/noncommunicable-diseases/ [6] Focus on populations facing extreme vulnerabilities, such as individuals or communities living in informal settlements, post-disaster settings, or in situations of homelessness is encouraged (though not required). [7] The following types of proposals are not in the scope of this topic: i) proposals with the primary aim of informing the development and/or selection of an intervention for a given context, where the implementation component will be explored in a future project (i.e. standalone feasibility projects); ii) epidemiological cohorts; iii) etiological work, mechanistic, or epidemiological research, unless an essential component of a focused study to develop implementation research approaches; iv) clinical trials, validation studies, or intervention efficacy studies for a new or established pharmacological agent or behavioural intervention. [8] Examples of frameworks include (this list is not exclusive): i) Consolidated Framework for Implementation Research (CFIR); ii) the context enhanced (RE-AIM) Reach, Effectiveness, Adoption, Implementation, Maintenance); iii) Practical Robust Implementation and Sustainability Model (PRISM) frameworks; iv) Framework for Developing and Evaluating Complex Interventions (MRC & NIHR). [9] https://pmc.ncbi.nlm.nih.gov/articles/PMC3731143 and https://pmc.ncbi.nlm.nih.gov/articles/PMC6779135 [10] The use of the term ‘racial or ethnic origin’ does not imply an acceptance of theories that attempt to determine the existence of separate human races. [11] The use of the term ‘racial or ethnic origin’ does not imply an acceptance of theories that attempt to determine the existence of separate human races. [12] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.

Eligibility and submission conditions

"> General conditions 1. Admissibility Conditions, proposal page limit and layout Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 2. Eligible Countries Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide . 3. Other Eligibility Conditions In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used). Other eligibility conditions are described in Annex B of the Work Programme General Annexes. 4. Financial and operational capacity and exclusion Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. 5a. Evaluation and award: Award criteria, scoring and thresholds Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual . 5c. Evaluation and award: Indicative timeline for evaluation and grant agreement Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. 6. Legal and financial set-up of the grants The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [This [decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf ]]. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions Specific conditions are described in the specific topic of the Work Programme. Application and evaluation forms and additional documents: Application and evaluation form templates Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations Guidance HE Programme Guide Model Grant Agreement (MGA) Lump Sum MGA Call-specific instructions   Information on clinical studies (HE) Detailed budget table (HE LS)   Guidance: "Lump sums - what do I need to know?" Additional documents HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health HE Main Work Programme 2026-2027 – 15. General Annexes HE Programme Guide HE Framework Programme 2021/695 HE Specific Programme Decision 2021/764 EU Financial Regulation 2024/2509 Decision authorising the use of lump sum contributions under the Horizon Europe Programme Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement

Programme context

Topics under this destination are directed towards the Key Strategic Orientation 3 “ A more resilient, competitive, inclusive, and democratic Europe ” of Horizon Europe’s strategic plan 2025-2027 [1] . Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “ healthcare providers improve their ability to tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) thereby reducing the disease burden on patients and enabling healthcare systems to perform more effectively. It can be achieved through better understanding, prevention, diagnostics, treatment, management, and cure of diseases and their co- and multi-morbidities, more effective and innovative health technologies and medical countermeasures, better ability and preparedness to manage pandemic and/or epidemic outbreaks, and improved patient safety ” . Communicable and non-communicable diseases pose a significant health, societal, and economic threat worldwide, causing premature deaths and disabilities. Despite being largely preventable, only 6% of healthcare budgets are spent on prevention [2] . To address this, there is an urgent need to develop new public health interventions, preventive, diagnostic, and therapeutic approaches, alternatives to antimicrobials, as well as to improve existing preparedness and response strategies to create tangible impacts, considering sex/gender-related issues. To address these challenges, Research and Innovation will require international cooperation to leverage global expertise, access world-class research infrastructures and invest in priority needs, aligning with other funders of international cooperation in health Research and Innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases and respond to public health needs, including rare diseases and the global burden of non-communicable diseases. In this Work Programme part, Destination “ Tackling diseases and reducing disease burden ” will focus on major societal challenges linked to the Commission's Political Guidelines for 2024-2029 [3] , such as the fight against non-communicable and communicable diseases, mental health, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment, of Antimicrobial-Resistant (AMR) infections, coherent also with wider EU initiatives such as the European Medical Countermeasures Strategy [4] and the forthcoming Critical Medicines Act [5] . In particular, the topics under this destination will support activities aiming at: i) new treatment and disease management options to reduce burden on non-communicable diseases and long-term conditions after post-bacterial and post-viral infections; ii) improve and protect mental health of children and young adults; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) innovative therapies for AMR critical pathogens; and v) support to second phases of the co-funded European Partnership on Rare Diseases [6] and the co-funded European Partnership for Pandemic Preparedness [7] . To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities, such as participating in joint workshops, exchanging knowledge, developing and adopting best practices, or undertaking joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic, as well as between projects funded under different topics, Clusters, or Pillars of Horizon Europe. For example, synergies could be sought with projects funded under the European health research infrastructures (Pillar I of Horizon Europe), the EIC [8] strategic challenges on health (Pillar III of Horizon Europe), or with projects on themes that cut across the Clusters under Pillar II of Horizon Europe, such as health security/emergencies under Cluster “Civil Security for Society”, Artificial Intelligence (AI)-based tools and technologies under Cluster “Digital, Industry and Space”, or antimicrobial resistance under Cluster “Food, Bioeconomy, Natural Resources, Agriculture and Environment”. The Commission aims to foster synergies between Horizon Europe and other EU programmes. To this end, applicants are encouraged to explore the funding opportunities available through the EU4Health Programme (2021-2027) [9] , the EU's public health programme, as a means of capitalising on potential collaborations and maximising impact. Expected impacts : Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts: Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare. Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases [10] , [11] are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs) [12] . Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide [13] , [14] , [15] . Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies). Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme. The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers [16] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details. [1] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/strategic-plan_en [2] Preventive healthcare expenditure as a share of the current expenditure on healthcare: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=File:Preventive_healthcare_expenditure_as_a_share_of_current_expenditure_on_healthcare,_2021_(%25)_HCE2024.png [3] https://commission.europa.eu/about/commission-2024-2029_en [4] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en [5] https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en [6] https://cordis.europa.eu/project/id/101156595 , https://erdera.org [7] https://cordis.europa.eu/project/id/101226682 , https://beready4pandemics.eu [8] https://eic.ec.europa.eu [9] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en [10] https://www.who.int/publications/i/item/9789241506236 [11] https://www.who.int/publications/m/item/implementation-roadmap-2023-2030-for-the-who-global-action-plan-for-the-prevention-and-control-of-ncds-2023-2030 [12] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death. [13] WHO global action plan on antimicrobial resistance, 2015 [14] EU One Health Action Plan against AMR, 2017 [15] https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agencies [16] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).

Hivatkozott dokumentumok

https://iris.who.int/bitstream/handle/10665/91758/9789241506212_eng.pdf Annex A Horizon Europe Programme Guide Online Manual [This [decision Standard application form (HE RIA, IA) Standard evaluation form (HE RIA, IA) Lump Sum MGA Information on clinical studies (HE) Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions