RELIEF aims to link European health procurers in order to create the innovative and sustainable solutions that will improve chronic pain control/relieve through ITC self-management techniques. Chronic pain diseases is costing to healthcare systems annually over €300bn in Europe; 1.5%-3% of GDP (gross domestic product). Chronic pain entails a significant direct cost to healthcare systems. Consultations with healthcare professionals confirm that Chronic pain associated costs are the largest share in healthcare system costs. Inappropriate and ineffective management and treatment generates repetitive visits to primary care physicians, and referrals to specialists. This has been identified as important drivers of avoidable healthcare costs. However, while direct costs are high, it has been estimated that nine-tenths of the burden of pain may fall on the broader society. Even small increases in the effectiveness of pain management reap large economic rewards. More than half of patients with acute or chronic pain are not well treated even though the existing therapeutic options have confirmed effective results. There is a clear heterogeneity in the treatments and also in the results. eHealth solutions must achieve greater comparability between systems, patients and protocols, so as to reach more effective and efficient procedures. At present, there is a wide range of high-tech devices aimed at treating pain in its many facets and complexity. But it is still necessary to cover the gap between Research and Commercialization of new products and devices, as outlined during the Pain Technology Transfer Forum, held in Madrid in July 2014. RELIEF will foster and accelerate the access to market for innovative solutions, while respecting the public procurement directives. The project will contribute to boost innovative tools that empower the patient to self-manage current and future pains.

Current evidence from both randomized trials and real-world evidence studies suggests that older breast cancer patients derive clinical benefit from the addition of CDK 4/6-inhibitors to endocrine therapy but with higher risk for adverse events and treatment discontinuation compared to younger patients. The IMPORTANT project will design and conduct a pragmatic clinical study with a decentralised approach for older patients with advanced breast cancer aiming at high level of evidence (level I) with multi-layer results that can enable changes in current clinical practice. This study will be conducted across 6 (six) EU countries, and will include more than 500 female and male patients. The project will also perform a series of analyses over a) a wide range of clinical-relevant primary and secondary endpoints targeting to contribute to current clinical practice and b) the implementation of specific strategies aiming at more individualized treatment and follow-up approaches to a clinical trial setting that highly resembles real-world setting due to the trial's pragmatic design. The project will be developed in 60 months by a competitive consortium of 19 partners from 11 countries, which corresponds to a well-balanced structure, involving clinical sites, SMEs, universities and patient advocacy organizations. Despite the great diversity of entities within the proposal, IMPORTANT partners bring state-of-the-art complementary skills ensuring the ability of the consortium to successfully complete the proposed work.This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.

ConcePTION partners have united around a shared vision that we have a societal obligation to radically and rapidly reduce uncertainty about the safety of medication use in pregnancy and lactation. What do we deliver? ConcePTION aims to create a paradigm shift in how we study medication safety in pregnancy. We will establish (1) a successful, sustainable open-science based EU non-proprietary ecosystem of public and private stakeholders, pregnant women and researchers to generate and disseminate timely and reliable evidence on drugs across maternal, neonatal and long term outcomes of medication exposure in pregnancy and breastfeeding (2) a catalogue with fully characterized data sources for rapid selection of suitable data sources; 3) operational, business, network, information and data governance models, (4) quality assured and tested methodological approaches, analytical tools and data platforms allowing for distributed analyses, (5) procedures and tools for collection of digital data and samples directly from pregnant women, (6) In vitro, in silico and in vivo models for prediction of drug transfer in human milk, (7) a biobank and analytical network for quantification of drug in human milk, (8) best practice documents endorsed by regulators and health authorities and (9) a web-based drug information knowledge bank. How do we deliver? (1) Experienced leaders, able to manage challenging networks and public-public or public-private partnerships. (2) Defragmentation by connecting all key stakeholders and EU networks in this area. (3) Re-use of data, tools and foreground from prior European commission funded projects. (4) Connecting to leaders of similar initiatives in the USA, Canada, Asia and other parts of the world. (5) Systematic consensus & endorsement building. (6) Quality throughout as a precondition to trust the results and information by all users.

Despite remarkable progress in the management of cardiovascular disease (CVD), major unmet needs remain with regard to mortality, hospitalisations, quality of life (QoL), healthcare expenditures and productivity. Acute coronary syndrome (ACS), atrial fibrillation (AF) and heart failure (HF) are major and growing components of the global CVD burden. Optimal management of these conditions is complicated by their complex aetiology and heterogeneous prognoses. Poor definition at the molecular level and co/multi-morbidities form major challenges for the development and delivery of targeted treatments. This renders response to therapy unpredictable, with large inter-individual variation and, importantly, small or undetectable treatment effects in large trials of unselected patients. Today’s treatment guidelines still reflect the scientific constraints of an earlier era where clinical markers to guide therapy are limited to conventional risk factors and end-organ damage, and where the main endpoint in clinical trials is patient death. Hence, drug development pipelines from early target validation through to late post-marketing work have proven to be slow, expensive and high-risk: the chance of eventual approval for a CVD drug candidate in Phase I trials is 7%, the lowest of any disease category (shared with oncology) 2. Moreover, tolerability of medication and adherence to treatment show wide variations. There is thus a need for better definition of these diseases, their markers and endpoints (including better segmentation of current heterogeneous patient groups acknowledging underlying mechanisms and comorbidities) and of their outcomes/prognoses (including functional capacity and quality of life [QoL]). BigData@Heart’s ultimate goal is to develop a Big Data--driven translational research platform of unparalleled scale and phenotypic resolution in order to deliver clinically relevant disease phenotypes, scalable insights from real-world evidence and insights driving

Millions of people in the EU are negatively affected by cancer, and cancer is one of the leading causes of death and morbidity in Europe (ecis.jrc.europa.eu). The PRIME-ROSE consortium will contribute to the Mission Cancer goal to optimise treatment and support quality of life of more than 3 million people by 2030. The PRIME-ROSE consortium envisions to support Mission Cancer through the following objectives: 1) increase access to optimised and affordable treatment interventions for cancer patients that prolong life and increase quality of life, 2) generate clinical evidence and evaluate effectiveness in Precision Cancer Medicine (PCM)-relevant and synthetically randomised, controlled academic investigator-initiated pragmatic clinical trials, and 3) work together across Europe with relevant experts to implement evidence-based PCM in routine practice and address inequalities in access. This consortium builds on the truly bottom-up, clinician-initiated family of DRUP-like innovative trials that provide broad access to precision medicine for cancer patients. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.