Polycystic Ovary Syndrome (PCOS) is the most prevalent, chronic endocrine-metabolic disorder of adolescents and young women (AYAs), affecting 5-10% of AYAs worldwide. It is the most frequent cause of anovulatory subfertility. There is no approved therapy for PCOS. Standard off-label treatment with oral contraceptives reverts neither the underlying pathophysiology nor the associated co-morbidities Pilot studies have generated new insights into the pathophysiology of PCOS, and have thus led to the development of a new approach wherein the PCOS phenotype is reverted without side effects. The novel medication is a fixed, low-dose combination of two insulin sensitisers [Pioglitazone (Pio), Metformin (Met)] and one mixed anti-androgen and anti-mineralocorticoid (Spironolactone (Spi)] within a single tablet: SPIOMET SPIOMET4HEALTH will test, in a multicentre Phase II trial, the additive effects of each SPIOMET component, on top of lifestyle measures in AYAs with PCOS. SPIOMET aims at normalising the ovulation rate and endocrine-metabolic status via the reduction of hepato-visceral fat excess, in an early phase of the disorder. This approach is expected to reduce the risk of morbidity (including subsequent anovulatory subfertility), to improve the quality of life, and to lower the economic burden on European healthcare systems. The consortium clusters the experts from key research groups working on PCOS in AYAs, across Europe. The design of SPIOMET4HEALTH foresees that the patients themselves will be engaged over the entire timespan of the project, and will also contribute to the ultimate study evaluation. The update and validation of PCOS-specific Patient Reported Outcome Measures (PROM) will provide the first large-scale evidence on the psychosocial benefits of the tested treatments. The collective evidence from SPIOMET4HEALTH, once completed with economic modelling, will lead to conclusions that inform sound decision-making about PCOS across European healthcare systems.

The e-Intervention Enhancing Mental Health in Adolescents project, IMPROVA, will co-design, pilot, evaluate, and facilitate the upscaling of a modular eHealth intervention platform that aims to improve mental health and well-being, early detect mental health problems and prevent common mental disorders in adolescents. The IMPROVA consortium includes an international and inter-disciplinary group of researchers and practitioners from health, educational and social sciences in addition to computer scientists, a teacher association and policymakers. The IMPROVA online platform will be co-created with stakeholder groups, including adolescents, parents, teachers, school health professionals and policymakers based on materials already designed and tested in more than 20 projects carried out by the consortium members. The platform will include components for adolescents, parents, teachers, and school health professionals in complementary and synergistic modules. After a series of pilot testing sessions, IMPROVA will be implemented by conducting a randomized Stepped Wedge Trial Design (SWTD) in secondary education schools randomly selected in four countries (France, Germany, Romania and Spain), including 12,800 adolescents. Effectiveness, cost-effectiveness and cost-benefit will be calculated. Using implementation science methodology, IMPROVA will co-design with policymakers and stakeholders transferable evidence-based practices, methodologies and guidance for upscaling of the IMPROVA platform. IMPROVA aims to provide stakeholders and policy makers with an evidence-based, innovative, large-scale, comprehensive intervention, and a scale-up plan to promote mental health and prevent mental disorders in adolescents; empower adolescents and families to make better decisions regarding their mental health; and provide schools and the community with tools to achieve a society with better mental health and lower stigma.

The public-private partnership, READI, seeks to help clinical studies (CS) to finally serve the complete general population, and therefore more patients. To date CS have struggled to recruit and retain participants from diverse backgrounds and communities, such as marginalized or disadvantaged groups (e.g., sexual, gender, age, cultural, and socioeconomic cohorts). The resulting knowledge gaps entrench or increase health disparities. The READI consortium strives to tackle these challenges by fostering a more cohesive and integrated CS ecosystem for underserved (US) and underrepresented (UR) communities. It will actively connect all key stakeholders who can facilitate access to a wide range of patient populations. It will provide these stakeholders with the necessary tools, training programs, and approaches essential for the recruitment and retention of US/UR patients in CS. In addition, it will design, build and implement a digital platform which is patient-centred, sustainable, open and innovative. This will foster improved access to CS information and READI tools, while also supporting patient connections with the created communities. Finally, at least 4 CS will be used for testing the effectiveness of the developed tools and approaches. READI has a three-fold objective: to help US/UR communities overcome CS participation barriers (e.g., lack of information/awareness, mistrust, poor communication, geographic limitations, prejudice), which in turn will improve research of many diseases and conditions, preventative care and treatment effectiveness in different demographic groups, and better serve society. READI’s success will draw from its interdisciplinary, multi-stakeholder, consortium composition of 73 organizations from 18 countries, with key expertise in drug development and CS (design and operations), engagement strategies for US/UR populations, digital platform development, training and capability building initiatives, effective communication and dissemination, long-term sustainability, ethics and regulatory affairs.

Background Health systems face a time of unprecedented change, with spiraling costs, increasing cultural disparity in access to healthcare and research, and an infrastructure that is decades old. Today, telehealth is a realistic alternative making care and research more accessible and personalised with less burden to better support the most vulnerable and under-served in our society. The ability to test and monitor for illnesses using Patient Centric micro-Sampling (PCmS) is at the centre of this reform. Aim and main objectives This project is designed to build upon existing pilots and knowledge, then collaborate cross-sectorially to co-create and test the logistics, infrastructure and tools required to make PCmS a core healthcare tool and an acceptable alternative to venous blood-draw across Europe. This project aligns with many IHI’s objectives focusing on cross-sectorial collaboration, emphasizing patient and end-user- centric co-design of outputs, harmonised regulatory and data generation approaches enhancing the potential of digital innovations in healthcare, while aiming to reduce the environmental footprint during the project and in final outputs to ensure that the expected long-term impact is a reachable reality that will deliver significant benefit to the community and address unmet public health needs at scale. To achieve our objectives, we bring together a broad group of required expertise, know-how and end-users (i.e., public and patients) to form a public-private-partnership specifically equipped to tackle this challenge. This collaborative approach where the relevant stakeholders such as healthcare professionals, regulatory agencies and patients are involved and integrated to deliver solutions and innovation across healthcare systems and ensure the best chances for success and long-term positive impact from this project. Key deliverables include: 1) An optimized, tested and validated ‘Gold Standard’ infrastructure and workflow for PCmS across Europe as a proven and reliable alternative to venipuncture 2) Harmonised and clear regulatory and HTA pathways, standards and acceptability, measures and cost-benefit models across Europe 3) Documented evidence to draw a citable ‘line in the sand’ for future research to support decisions to integrate PCmS into decentralised trials and care pathways 4) Stakeholder engagement and patient involvement models and research on preferences and acceptability for PCmS 5) Foundation for future: Enable access to the developed PCmS scientific findings, tools and assessment measures for rapid uptake and integration of PCmS approaches into decentralised clinical studies and healthcare Expected impact: - Patient-centric microsampling becomes an accepted alternative to the current standard of care venipuncture and the data gathered can be leveraged in healthcare planning. - Lowered patient burden and lowered barrier to access in situations where blood samples need to be collected, whether as part of diagnosis, care plan, health monitoring etc. - A solution to leverage high amounts of data gathered from increased testing can be explored already in this project so that it can pave the way for future research that can improve health outcomes.

Innovation in paediatric health is critical to ensure that children, regardless of their age, health condition, socio-economic situation or place of birth, have access to the life-changing healthcare solutions they need to grow-up stronger and contribute to a better society. Children are not just small adults and they need targeted innovative solutions. However, paediatric innovation is still elusive. There are two main causes for this: i) Stakeholders perceive paediatric innovation as risky and they just try to adapt adult solutions to children. ii) Paediatric experts, innovators and other relevant stakeholders are scattered in a fragmented ecosystem across Europe failing to identify opportunities or deliver effective and harmonized action. Thus, the unexploited innovation potential is large, particularly in emerging and moderate innovator countries. To reduce barriers and exploit these opportunities, while ensuring equality across different countries, the establishment of a European Paediatric Innovation Ecosystem is of paramount importance. The i4KIDS-EUROPE project builds on an existing successful initiative (i4KIDS), and it will expand its activities towards Europe in order to enlarge the participation of diverse European paediatric stakeholders and territories. The project will allow synergies, avoid duplications, reduce differences between strong and emerging/moderate innovator territories and strengthen competitiveness to optimise the innovation potential of the European paediatric sector. To achieve this, we will analyse the landscape of paediatric innovation in Europe as well as the barriers that emerging/moderate innovator countries face. i4KIDS-EUROPE will offer an interconnected paediatric innovation ecosystem that will capacitate its underrepresented actors and make them participate in the design of the future European Paediatric Innovation Ecosystem.