Exploring the connection between EU-funded research and methodological approaches: insights from a retrospective analysis.

BACKGROUND: Over the last two decades, substantial investments have been directed towards supporting fundamental and applied research in Alzheimer's disease (AD), breast cancer (BC), and prostate cancer (PC), which continue to pose significant health challenges. Recently, the Joint Research Centre (JRC) of the European Commission (EC) conducted a retrospective analysis to examine the major scientific advancements resulting from EU-funded research in these disease areas and their impact on society. METHODS: Building upon this analysis, our subsequent investigation delves into the methodological approaches-both animal and non-animal models and methods-employed in AD, BC, and PC research funded under past EU framework programs (FP5, FP6, FP7, and H2020), and explored the notable research outputs associated with these approaches. RESULTS: Our findings indicate a prevalent use of animal-based methodologies in AD research, particularly evident in projects funded under H2020. Notably, projects focused on drug development, testing, or repurposing heavily relied on animal models. Conversely, research aimed at clinical trial design, patient stratification, diagnosis and diagnostic tool development, lifestyle interventions, and prevention-outputs with potential societal impact-more frequently utilised non-animal methods. Advanced investigations leveraging imaging, computational tools, biomarker discovery and organ/tissue chip technologies predominantly favoured non-animal strategies. CONCLUSIONS: These insights highlight a correlation between methodological choices and the translational potential of research outcomes, suggesting the need for a reconsideration of research strategy planning in future framework programs.

Protecting whose welfare? A document analysis of competition regulatory decisions in four jurisdictions across three harmful consumer product industries.

BACKGROUND AND METHODS: Competition regulation has a strong influence on the relative market power of firms. As such, competition regulation can complement industry-specific measures designed to address harms associated with excessive market power in harmful consumer product industries. This study aimed to examine, through a public health lens, assessments and decisions made by competition authorities in four jurisdictions (Australia, South Africa, the United States (US), and the European Union (EU)) involving three harmful consumer product industries (alcoholic beverages, soft drinks, tobacco). We analysed legal case documents, sourced from online public registers and dating back as far as the online records extended, using a narrative approach. Regulatory decisions and harms described by the authorities were inductively coded, focusing on the affected group(s) (e.g., consumers) and the nature of the harms (e.g., price increases) identified. RESULTS: We identified 359 cases published by competition authorities in Australia (n = 202), South Africa (n = 44), the US (n = 27), and the EU (n = 86). Most cases (n = 239) related to mergers and acquisitions (M&As). Competition authorities in Australia, the US, and the EU were found to make many decisions oriented towards increasing the affordability and accessibility of alcohol beverages, soft drinks, and tobacco products. Such decisions were very often made despite the presence of consumption-reduction public health policies. In comparison, South Africa's competition authorities routinely considered broader issues, including 'Black Economic Empowerment' and potential harms to workers. CONCLUSION: Many of the competition regulatory decisions assessed likely facilitated the concentration of market power in the industries we explored. Nevertheless, there appears to be potential for competition regulatory frameworks to play a more prominent role in promoting and protecting the public's health through tighter regulation of excessive market power in harmful consumer product industries.

Enhancing landfill efficiency to drive greenhouse gas reduction: A comprehensive study on best practices and policy recommendations.

This article investigates the pivotal role of non-hazardous waste landfills in achieving greenhouse gas (GHG) reduction objectives within the European Union (EU).1 This study leverages the experience of key stakeholders in the European landfilling, assesses the efficacy of 'best-in-class' landfill installations, evaluates their potential impact on GHG reduction, and offers concrete recommendations for operators and policymakers. 'Best-in-class' landfills exceed the commonly accepted best practices by implementing all the following practices: (1) an anticipated capture system during the operating phase, (2) prompt installation of the final cover and capture system, with use of an impermeable cover, (3) operated as bioreactor, keeping optimal humidity, (4) adequate maintenance and reporting, (5) recovery of captured gas and (6) treatment of residual methane emissions throughout the waste decomposition process. The main finding is that switching from the actual mix of practices to 'best in class' practices would reduce by ~21 MtCO2eq (-36%) the emissions due to the degradation of waste landfilled between 2024 and 2035, compared to the 'business-as-usual scenario', while also providing a renewable energy source, bringing potential avoided emissions and energy sovereignty. The findings underscore that in addition to implementing the organics diversion and waste reduction targets of the EU, adopting 'best-in class' landfill practices has the potential to bolster energy recovery, mitigate emissions and stimulate biomethane production, thereby advancing the EU environmental goals.

Self-medication among general population in the European Union: prevalence and associated factors.

Self-medication (SM) forms an important part of public health strategy. Nonetheless, little research has been performed to understand the current state of self-medication in the European Union (EU). Utilizing data from the third wave of the European Health Interview Surveys, this study finds an estimated SM prevalence of 34.3% in the EU (95%CI = 34.1-34.5%; n = 255,758). SM prevalence, as well as SM prevalence inequality between men and women, varies substantially between EU member countries. Via multivariable analysis, we also identify a number of variables associated with SM, most notably the substantial impact of health systems on SM behavior (Adjusted Odds Ratio [AOR] = 4.00; 95% Confidence Interval [95%CI] = 3.81-4.21). Several demographics are also associated with greater SM prevalence, including those aged 25-44 (versus ages 75+: AOR = 1.21; 95%CI = 1.12-1.31), women (AOR = 1.74; 95%CI = 1.68-1.81), immigrants born in other EU states (AOR = 1.16; 95%CI = 1.04-1.30), those with higher education (AOR = 1.83; 95%CI = 1.60-2.09), and urban dwellers (AOR = 1.14; 95%CI = 1.04-1.30). Additionally, long-standing health problems (AOR = 1.39; 95%CI = 1.33-1.45), visits to doctors (both general practitioners and specialists) (AOR = 1.21, 95%CIs = 1.15-1.26, 1.17-1.26), and unmet needs for health care due to waiting lists (AOR = 1.38; 95%CI = 1.23-1.55) or inability to afford medical examinations/treatment (AOR = 1.27; 95%CI = 1.12-1.42) serve as conditioners for SM. We also find that smoking (AOR = 1.05; 95%CI = 1.01-1.10), vaping (AOR = 1.19; 95%CI = 1.06-1.32), drinking alcohol (AOR = 1.23; 95%CI = 1.19-1.28), and higher levels of physical activity (AOR = 1.27; 95%CI = 1.22-1.32) are factors associated with SM. Analysis of these variables reveals that though women self-medicate more than men, the patterns that govern their consumption are similar.

Continuing Education in Digital Skills for Healthcare Professionals - Mapping of the Current Situation in EU Member States.

The rapid advancement of technology in healthcare is creating new competency requirements for professionals, such as skills for data management and the adoption of new technologies, understanding the effect of digitalisation on clinical processes, and evaluating clinical safety and ethics within the context of digitalisation. These requirements call for improved educational curricula and ongoing continuing education in digital skills. This study, as part of the Digital Skills Training for Health Care Professionals in Oncology (DigiCanTrain) project, aims to map and describe the existing continuing education in digital skills for healthcare professionals (HCPs) in European Union (EU) Member States. Using a mapping study methodology, data was collected from experts in 25 EU countries through surveys and from online sources. Qualitative content analysis was used for categorising the data. The results show variations between countries in policy strategies, training organisation, and funding mechanisms. Educational institutions, employers, third parties, and national/regional authorities were found to be the main organisers of the digital skills training. Comprehensive accreditation systems seemed to be scarce, and practices also varied between countries. The study highlights the importance of adopting a systematic approach to enhancing continuous professional development in digital skills, which would ensure that professionals have equitable access to education, resulting in consistent, quality patient care across countries and regions. The findings offer valuable insights for policymakers, educators, healthcare institutions, and professionals.

What public health challenges and unmet medical needs would benefit from interdisciplinary collaboration in the EU? A survey and multi-stakeholder debate.

In the past decade, significant European calls for research proposals have supported translational collaborative research on non-communicable and infectious diseases within the biomedical life sciences by bringing together interdisciplinary and multinational consortia. This research has advanced our understanding of disease pathophysiology, marking considerable scientific progress. Yet, it is crucial to retrospectively evaluate these efforts' societal impact. Research proposals should be thoughtfully designed to ensure that the research findings can be effectively translated into actionable policies. In addition, the choice of scientific methods plays a pivotal role in shaping the societal impact of research discoveries. Understanding the factors responsible for current unmet public health issues and medical needs is crucial for crafting innovative strategies for research policy interventions. A multistakeholder survey and a roundtable helped identify potential needs for consideration in the EU research and policy agenda. Based on survey findings, mental health disorders, metabolic syndrome, cancer, antimicrobial resistance, environmental pollution, and cardiovascular diseases were considered the public health challenges deserving prioritisation. In addition, early diagnosis, primary prevention, the impact of environmental pollution on disease onset and personalised medicine approaches were the most selected unmet medical needs. Survey findings enabled the formulation of some research-policies interventions (RPIs), which were further discussed during a multistakeholder online roundtable. The discussion underscored recent EU-level activities aligned with the survey-derived RPIs and facilitated an exchange of perspectives on public health and biomedical research topics ripe for interdisciplinary collaboration and warranting attention within the EU's research and policy agenda. Actionable recommendations aimed at facilitating the translation of knowledge into transformative, science-based policies are also provided.

Welcoming the future: embracing novel technologies for a progressive health system.

BACKGROUND: Novel technologies offer great possibilities for improving patient care, but their adoption varies across different European countries. To successfully integrate these advancements, it is crucial to prioritize patient interests and avoid getting side-tracked by issues that seek to preserve established positions or neglect collaboration. Next-generation sequencing and liquid biopsy in cancer patients hold substantial potential for early diagnosis and reducing suffering, but only if they are effectively implemented into routine health care. METHODS: An examination of the infrastructure and governance requirements in European member states was conducted to identify significant gaps and discrepancies in the readiness to capitalize on the benefits that these technologies can provide. RESULTS: These disparities highlight the existing inequalities and missed opportunities within the European Union (EU), which are further exacerbated by varying economic statuses. CONCLUSIONS: As Europe undergoes a comprehensive review of its health policies and public spending between 2024 and 2025, it is an opportune time to prioritize ensuring that patients can access the advancements offered by technology and science.

Delayed treatment in breast cancer patients during the COVID-19 pandemic: a population health information research infrastructure (PHIRI) case study.

BACKGROUND: The indirect impact of the coronavirus disease 2019 pandemic on healthcare services was studied by assessing changes in the trend of the time to first treatment for women 18 or older who were diagnosed and treated for breast cancer between 2017 and 2021. METHODS: An observational retrospective longitudinal study based on aggregated data from four European Union (EU) countries/regions investigating the time it took to receive breast cancer treatment. We compiled outputs from a federated analysis to detect structural breakpoints, confirming the empirical breakpoints by differences between the trends observed and forecasted after March 2020. Finally, we built several segmented regressions to explore the association of contextual factors with the observed changes in treatment delays. RESULTS: We observed empirical structural breakpoints on the monthly median time to surgery trend in Aragon (ranging from 9.20 to 17.38 days), Marche (from 37.17 to 42.04 days) and Wales (from 28.67 to 35.08 days). On the contrary, no empirical structural breakpoints were observed in Belgium (ranging from 21.25 to 23.95 days) after the pandemic's beginning. Furthermore, we confirmed statistically significant differences between the observed trend and the forecasts for Aragon and Wales. Finally, we found the interaction between the region and the pandemic's start (before/after March 2020) significantly associated with the trend of delayed breast cancer treatment at the population level. CONCLUSIONS: Although they were not clinically relevant, only Aragon and Wales showed significant differences with expected delays after March 2020. However, experiences differed between countries/regions, pointing to structural factors other than the pandemic.

Protecting cancer survivors from financial discrimination throughout the EU: A cross-European perspective.

This article provides an overview of the High-Level Conference on Ending Financial Discrimination Against Cancer Survivors held on the 15th of February 2024, in Brussels, Belgium. Organised under the auspices of the Belgian Presidency of the European Council and led by the European Initiative on Ending Discrimination Against Cancer Survivors, the focus was the "right to be forgotten" (RTBF), which seeks to prevent financial discrimination against former cancer patients by ensuring their medical history is not considered by insurers and lenders 5 years after the end of treatment and without recurrence of the disease. Through detailed discussions and poignant testimonies, the conference shed light on the profound impact of financial discrimination on cancer survivors' lives and the moral and legal imperatives to address it. The article concludes with recommendations for advancing RTBF legislation at both national and European levels, emphasising the importance of political will, medical research, and strong advocacy from the cancer community.

Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.

Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization based on surrogate end points and pending confirmatory trials. In this cross-sectional study, we considered 23 indications of cancer drugs that received accelerated approval by the US Food and Drug Administration (FDA) but were subsequently withdrawn as of April 2023. Our investigation extended to assessing the regulatory status of these accelerated approvals in the European Union (EU) and Japan, examining relevant regulatory documents and identifying factors contributing to the withdrawal in the United States. Comparing regions, we found that for 52% (12/23) and 30% (7/23) of withdrawn accelerated approvals in the United States, sponsors had also sought marketing authorization from the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), respectively. As of the April 30, 2023 study cutoff date, 83% (10/12) of drug-indication pairs remained approved by the EMA, while the PMDA retained 100% (7/7). For these indications, the time from FDA withdrawal until the study cutoff date ranged from 0.23 years to 11.45 years for EMA approvals (median: 1.28 years) and 1.10 years to 11.45 years for PMDA approvals (median: 3.22 years). These findings highlight substantial regulatory discrepancies concerning cancer drugs with unconfirmed benefits. Addressing these discrepancies may involve requiring pharmaceutical companies to confirm clinical benefits using more robust end points and fostering international harmonization in regulators' assessment.

Regulatory landscape and challenges in CAR-T cell therapy development in the US, EU, Japan, and India.

Chimeric Antigen Receptor-T cell (CAR-T) therapy has evolved as a revolutionary cancer treatment modality, offering remarkable clinical responses by harnessing the power of a patient's immune system to target and eliminate cancer cells. However, the development and commercialization of CAR-T cell therapies are accompanied by complex regulatory requirements and challenges. This therapy falls under the regulatory category of advanced therapy medicinal products. The regulatory framework and approval tools of regenerative medicine, especially CAR-T cell therapies, vary globally. The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four key regions: the United States, the European Union, Japan, and India. This work explores the unique requirements and considerations for preclinical studies, clinical trial design, manufacturing standards, safety evaluation, and post-marketing surveillance in each jurisdiction. Due to their complex nature, developers and manufacturers face several challenges. In India, despite advancements in treatment protocols and government-sponsorships, there are still several difficulties regarding access to treatment for the increasing number of cancer patients. However, India's first indigenously developed CAR-T cell therapy, NexCAR19, for B-cell lymphoma or leukemia, approved and available at a low cost compared to other available CAR-T therapies, raises great hope in the battle against cancer. Several strategies are proposed to address the identified hurdles from global and Indian perspectives. It discusses the benefits of aligning regulatory requirements across regions, eventually facilitating international development and enabling access to this transformative therapy.

Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures.

INTRODUCTION: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA. AREAS COVERED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan. EXPERT OPINION: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.

Exposure to volatile organic compounds in offices and in residential and educational buildings in the European Union between 2010 and 2023: A systematic review and health risk assessment.

Chronic exposure to indoor volatile organic compounds (VOCs) can result in several adverse effects including cancers. We review reports of levels of VOCs in offices and in residential and educational buildings in the member states of the European Union (EU) published between 2010 and 2023. We use these data to assess the risk to population health by estimating lifetime exposure to indoor VOCs and resulting non-cancer and cancer risks and, from that, the burden of cancer attributable to VOC exposure and associated economic losses. Our systematic review identified 1783 articles, of which 184 were examined in detail, with 58 yielding relevant data. After combining data on VOC concentrations separately for EU countries and building types, non-cancer and cancer risks were assessed in terms of hazard quotient and lifetime excess cancer risk (LECR) using probabilistic Monte Carlo Simulations. The LECR was used to estimate disability adjusted life years (DALYs) from VOC-related cancers and associated costs. We find that the LECR associated with formaldehyde exposure was above the acceptable risk level (ARL) in France and Germany and that of from exposure to benzene was also above the ARL in Spanish females. The sum of DALYs and related costs/1,000,000 population/year from exposure to acetaldehyde, benzene, formaldehyde, tetrachloroethylene, and trichloroethylene were 4.02 and €41,010, respectively, in France, those from exposure to acetaldehyde, benzene, carbon tetrachloride, formaldehyde, and trichloroethylene were 3.91 and €39,590 in Germany, and those from exposure to benzene were 0.1 and €1030 in Spain. Taken as a whole, these findings show that indoor exposure to VOCs remains a public health concern in the EU. Although the EU has set limits for certain VOCs, further measures are needed to restrict the use of these chemicals in consumer products.

Genetic counselling legislation and practice in cancer in EU Member States.

BACKGROUND: Somatic and germline genetic alterations are significant drivers of cancer. Increasing integration of new technologies which profile these alterations requires timely, equitable and high-quality genetic counselling to facilitate accurate diagnoses and informed decision-making by patients and their families in preventive and clinical settings. This article aims to provide an overview of genetic counselling legislation and practice across European Union (EU) Member States to serve as a foundation for future European recommendations and action. METHODS: National legislative databases of all 27 Member States were searched using terms relevant to genetic counselling, translated as appropriate. Interviews with relevant experts from each Member State were conducted to validate legislative search results and provide detailed insights into genetic counselling practice in each country. RESULTS: Genetic counselling is included in national legislative documents of 22 of 27 Member States, with substantial variation in legal mechanisms and prescribed details (i.e. the 'who, what, when and where' of counselling). Practice is similarly varied. Workforce capacity (25 of 27 Member States) and genetic literacy (all Member States) were common reported barriers. Recognition and/or better integration of genetic counsellors and updated legislation and were most commonly noted as the 'most important change' which would improve practice. CONCLUSIONS: This review highlights substantial variability in genetic counselling across EU Member States, as well as common barriers notwithstanding this variation. Future recommendations and action should focus on addressing literacy and capacity challenges through legislative, regulatory and/or strategic approaches at EU, national, regional and/or local levels.

Mortality trends in idiopathic pulmonary fibrosis in Europe between 2013 and 2018.

BACKGROUND: Previous research has suggested that the incidence of idiopathic pulmonary fibrosis (IPF) is increasing in the UK and elsewhere. The aim of this study is to provide contemporary estimates of IPF mortality rates across 24 European Union (EU) countries from 2013 to 2018, using death certificate data from the European Statistics Institution (EUROSTAT) database. METHODS: We extracted country data for IPF (International Classification of Diseases, 10th Revision: code J84.1) mortality from the EUROSTAT dataset. We calculated country-, age- and sex-specific death registration rates between 2013 and 2018. We used direct standardisation to compare rates between countries. We calculated annual trends in mortality rate ratios using a segmented regression model. RESULTS: The overall standardised mortality rate in 24 EU countries during this period was 3.90 (95% CI 3.80-3.90) per 100 000 person-years, with the rate rising from 3.70 in 2013 to 4.00 in 2018 (average annual percent change 1.74%, 95% CI 0.91-2.59%). We observed substantial inter-country differences, with the highest rates detected in Ireland, the UK and Finland, the lowest rate in Bulgaria, and middle rates in Germany, Greece, Italy, the Netherlands, Portugal and Slovenia. CONCLUSIONS: The IPF mortality rate is increasing across Europe. There are currently more than 17 000 deaths recorded from IPF each year in Europe but the marked geographical differences we observed suggest that this figure may underestimate the true rate considerably.

EU's Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results.

BACKGROUND: The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021-2022. METHODS: The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0-2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0-2 scale. RESULTS: All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0-0.15 and 0.15-0.69, respectively, in the biological domain, and 0.12-0.55 and 0.23-0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues. CONCLUSION: Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.

The science and practice of current environmental risk assessment for gene therapy: a review.

Gene therapy is a fast-growing field showing great potential to treat genetic diseases and cancer. With accelerating gene therapy development and approval, their environment risk assessment (ERA) becomes increasingly important. An ERA is an assessment of the risks to human health and the environment upon exposure to a medicinal product as the result of its release during clinical development or after entering the market. Because ERA is an important component of regulatory submission, drug developers must perform a robust assessment to ensure the safety of unintended persons, animal, plants, microorganisms and environment at large. Global regulations on gene therapy ERA continue to evolve. Gene therapy ERAs are carried out according to general principles as provided in regulatory guidelines for application of clinical trials and marketing authorizations. The current review intends to summarize regulations and content requirements on gene therapy ERA in European Union, the USA and Japan. The approved gene therapy products by EMA and US Food and Drug Administration are analyzed for the critical aspects of their ERAs to provide the current status and practice of gene therapy ERAs by drug developers. For this purpose, the main contents of these gene therapy ERAs are summarized. Critical safety factors of gene therapy ERAs are described. With more experience and knowledge to be accumulated, gene therapy ERAs are expected to be less challenging with commonly used viral vectors.

The development of an EU-wide nutrition and physical activity expert knowledge base to support a personalised mobile application across various EU population groups.

A healthy lifestyle comprising regular physical activity and an adequate diet is imperative for the prevention of non-communicable diseases such as hypertension and some cancers. Advances in information computer technology offer the opportunity to provide personalised lifestyle advice directly to the individual through devices such as smartphones or tablets. The overall aim of the PROTEIN project (Wilson-Barnes et al., 2021) was to develop a smartphone application that could provide tailored and dynamic nutrition and physical activity advice directly to the individual in real time. However, to create this mobile health (m-health) smartphone application, a knowledge base of reference ranges for macro-/micronutrient intake, anthropometry, biochemical, physiological and sleep parameters was required to underpin the parameters of the recommender systems. Therefore, the principal aim of this emerging research paper is to describe the process by which experts in nutrition and physiology from the PROTEIN consortium collaborated to develop the nutritional and physical activity requirements, based upon existing recommendations, for 10 separate population groups living within the EU including, but not limited to healthy adults, adults with type 2 diabetes mellitus, cardiovascular disease, excess weight, obesity and iron deficiency anaemia. A secondary aim is to describe the development of a library of 24-h meal plans appropriate for the same groups and also encompassing various dietary preferences and allergies. Overall, the consortium devised an extensive nutrition and physical activity knowledge base that is pertinent to 10 separate EU user groups, is available in 7 different languages and is practically implemented via a library of culturally appropriate, 24-h meal plans.

PCM4EU and PRIME-ROSE: Collaboration for implementation of precision cancer medicine in Europe.

BACKGROUND: In the two European Union (EU)-funded projects, PCM4EU (Personalized Cancer Medicine for all EU citizens) and PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials), we aim to facilitate implementation of precision cancer medicine (PCM) in Europe by leveraging the experience from ongoing national initiatives that have already been particularly successful. PATIENTS AND METHODS: PCM4EU and PRIME-ROSE gather 17 and 24 partners, respectively, from 19 European countries. The projects are based on a network of Drug Rediscovery Protocol (DRUP)-like clinical trials that are currently ongoing or soon to start in 11 different countries, and with more trials expected to be established soon. The main aims of both the projects are to improve implementation pathways from molecular diagnostics to treatment, and reimbursement of diagnostics and tumour-tailored therapies to provide examples of best practices for PCM in Europe. RESULTS: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: European collaboration can facilitate the implementation of PCM and thereby provide affordable and equitable access to precision diagnostics and matched therapies for more patients.