AI-based decision support systems are increasingly deployed in industry, in the public and private sectors, and in policy-making. As our society is facing a dramatic increase in inequalities and intersectional discrimination, we need to prevent AI systems to amplify this phenomenon but rather mitigate it. To trust these systems, domain experts and stakeholders need to trust the decisions. Fairness stands as one of the main principles of Trustworthy AI promoted at EU level. How these principles, in particular fairness, translate into technical, functional social, and lawful requirements in the AI system design is still an open question. Similarly we don’t know how to test if a system is compliant with these principles and repair it in case it is not. AEQUITAS proposes the design of a controlled experimentation environment for developers and users to create controlled experiments for - assessing the bias in AI systems, e.g., identifying potential causes of bias in data, algorithms, and interpretation of results, - providing, when possible, effective methods and engineering guidelines to repair, remove, and mitigate bias, - provide fairness-by-design guidelines, methodologies, and software engineering techniques to design new bias-free systems The experimentation environment generates synthetic data sets with different features influencing fairness for a test in laboratories. Real use cases in health care, human resources and social disadvantaged group challenges further test the experimentation platform showcasing the effectiveness of the solution proposed. The experimentation playground will be integrated on the AI-on-demand platform to boost its uptake, but a stand-alone release will enable on-premise privacy-preserving test of AI-systems fairness. AEQUITAS relies on a strong consortium featuring AI experts, domain experts in the use case sectors as well as social scientists and associations defending rights of minorities and discriminated groups.

Over 30% of EU citizens at vulnerable stages and situations in life are at increased risk to transgress from healthy weight to overweight and further to obesity. Though many interventions to tackle obesity have been proposed, they have rarely been effective. The aim of HealthyW8 is to advance the efficacy of current and future efforts and investments in obesity prevention initiatives across Europe. Most interventions suffer from not adapting to personal context (e.g. socioeconomic aspects, host-biological factors, environment, dietary preferences, fitness level etc.), focus only on diet or physical activity alone, do especially overlook emotional aspects, and fail to engage and motivate the user. Thus, initiatives on obesity prevention in policy and practice are often of marginal impact. HealthyW8 will address these shortcomings by iteratively developing, together with stakeholders, a digital-based healthy lifestyle recommender for evidence-based, tailored interventions and tools including a human digital twin to bridge the gap between science, societal actors and stakeholders (e.g. healthcare professionals, food industries, policymakers) and EU citizens. The targeted populations are those undergoing transitions, i.e. schoolchildren (5-10 y, and their parents), young adults (18-25 y) and the elderly (>65 y). In the mid-term, we estimate that with 200,000 HealthyW8 users, we will prevent 10,000 obesity cases/y. In the long run, the impact will be maximized through adopting the project’s proposed methodology, platform and tools by as many EU institutions and entities as possible. HealthyW8 is a highly experienced, synergistic and complementary consortium that will built on a previously developed digital dietary app (LIFANA) and draw on transdisciplinary research in pan-EU multicentre pilots and long-term randomized control trials to achieve its overarching objective of increasing impact of current and future obesity prevention interventions and policies in the EU.

Our proposal encompasses parallel clinical trials addressing the feasibility and the effectiveness of donor-derived regulatory T cells (Treg) as a therapeutic agent in the treatment and prevention of tissue and organ damage resulting from graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). We propose a collaborative clinical study in which Treg therapy for GHVD is the common dominator. However, by bringing together several clinical centers with expertise in this area, we are also having the opportunity to simultaneously address other issues that would not otherwise be addressable by each clinical center on its own. Firstly, by using different Treg preparation strategies, we will be able to determine whether ex vivo isolated Treg are sufficient or whether in vitro expansion and subsequently higher dosages are required. Secondly, we will investigate if sole Treg infusion is effective or if rather co-administration of therapeutic agents that are likely to induce Treg survival and expansion in vivo (rapamycin; IL-2) is required for a successful response to Treg therapy. The studies on GVHD treatment outcome will be pursued together with a detailed analysis of immune monitoring, comprising T cell receptor clonotype tracking and tissue regeneration markers, in order to further understand the mechanisms underlying the therapeutic and regenerative potential of Treg cells. Our consortium has developed a concerted approach to the topic of Treg therapy in GVHD. This is a unique opportunity to determine the validity of this cellular immunotherapy approach in GVHD prevention and treatment, with potential for a significant impact on patient quality of life, survival rate and ultimately on the quality of health care provided.

Anxiety disorders’ diagnosis, decision and treatment processes are still uncertain and inconsistent especially in a fast-evolving real world where stressors affect people in different ways. SMILE aims to improve the quality of mental health management and ensure affordable services by sharing information, providing scalable digital tools, and ensuring personalized decision-making and evidence-based interventions in an effective way. To achieve these goals, SMILE will develop mainly Open Knowledge Platform (OKP) and interactive gamification tools. OKP will bring together healthcare professionals, scientists, policymakers, businesses, and citizens to co-design effective decision strategies and unlock access to meaningful knowledge. Gamification will provide self-assessment, learning, and self-care services for young people to develop thinking, coping, and doing skills. Hence, SMILE will be able to integrate and analysis at least 7 different diagnostic data from clinical data to daily living parameters. Also, SMILE will assist primarily clinicians and help patients through 3 decision-making tools. The analytics and predictive tools will support practitioners in understanding the associations between risk factors, and anxiety, and recommending interventions in a personalized way. The SMILE digital tools and services will be implemented and validated in eight real-life strategic case studies, in 7 different European countries: UK, Germany, Cyprus, Poland, Slovenia, Spain and Italy, to reach TRL 7. Also, a systematic upscaling method will be deployed to sustain our program and ensure the continuity in the post-project. SMILE will deliver durable legal, socio-economic, gender and environmental values for the benefit of healthcare professionals, patients, EU SMEs and society at large. Finally, SMILE has strong multidisciplinary skills and is composed of one leading research center, 5 SMEs, 3 pilot centers, 4 public universities, and 1 policymaker from 9 European countries.

PREMIO COLLAB’s vision is to prolong overall survival and improve the quality of life for patients with metastatic breast cancer (MBC) by providing refined guidance for managing response monitoring. PREMIO COLLAB strives to facilitate improved patient care and streamlined clinical workflows addressing the needs of patients, healthcare professionals, and society. Response evaluation methods for patients with MBC have not been modernised for decades, although molecular imaging with FDG-PET/CT has emerged as a highly accurate method for staging MBC, and staging and monitoring MBC has a profound influence on treatment options and the chances of survival. Furthermore, the patient perspective has rarely been considered, although continuous response evaluation in a monitoring setting has interacted with the life of MBC patients for years. Still, no specific recommendations are provided internationally for response evaluation in MBC or in the overall management of monitoring. PREMIO COLLAB offers complementary competencies in an interdisciplinary collaborative effort to lift this complex task. In a pragmatic multicenter randomised clinical trial (RCT), we will apply the intervention of FDG-PET/CT-based monitoring and compare it with conventional CT as state-of-the-art. The objectives are to analyse the impact of the intervention on overall survival and quality of life in patients with MBC and include cost-effectiveness analyses directly informing HTA agencies and health policymakers. Building on knowledge from the RCT, we will use participatory research designs to develop improved and modernised patient pathways and digital workflows. AI-based solutions in imaging and liquid biopsies constitute perspectives with a broader horizon. The work will be done in multiple European centres and living labs with patient representatives, clinicians, and relevant stakeholders aiming to provide knowledge for updated recommendations with a view to subsequent clinical implementation. This action is part of the Cancer Mission cluster of projects on ‘‘Diagnostics and Treatment (diagnostics).”