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In the year 2000, cancer research in Europe had the potential to make a difference as it had several unique strengths, such as a strong foundation in biomedical science, good patient registries, infrastructures that spanned from biological repositories to bioinformatic hubs as well as thriving Comprehensive Cancer Centers (CCCs) and basic/preclinical cancer research institutions of high international standing. Research, however, was fragmented and lacked coordination. As a result, Europe could not harness its potential for translating basic research discoveries into a clinical setting for the patients' benefit. What was needed was a paradigm shift in cancer research that addressed the translational research continuum. Along these lines, in 2000, European Union (EU) Commissioner Philippe Busquin established the European Research Area (ERA) and in 2002 the European Cancer Research Area (ECRA), and their political approval was a powerful catalyst for the increased involvement of scientists in science policy in the EU. In this report, we briefly describe the actions embraced by the cancer community and cancer organizations in response to Busquin's proposals that led to the creation of the EU Mission on Cancer (MoC) in Horizon 2020 in 2021., (© 2024 The Authors. Molecular Oncology published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.)

Introduction: The second annual 5-day workshop on Principles and Techniques for Improving Preclinical to Clinical Translation in Alzheimer's Disease Research was held October 7-11, 2019, at The Jackson Laboratory in Bar Harbor, Maine, USA, and included didactic lectures and hands-on training. Participants represented a broad range of research across the Alzheimer's disease (AD) field, and varied in career stages from trainees and early stage investigators to established faculty, with attendance from the United States, Europe, and Asia., Methods: In line with the National Institutes of Health (NIH) initiative on rigor and reproducibility, the workshop aimed to address training gaps in preclinical drug screening by providing participants with the skills and knowledge required to perform pharmacokinetic, pharmacodynamics, and preclinical efficacy experiments., Results: This innovative and comprehensive workshop provided training in fundamental skill sets for executing in vivo preclinical translational studies., Discussion: The success of this workship is expected to translate into practical skills that will enable the goals of improving preclinical to clinical translational studies for AD., Highlights: Nearly all preclinical studies in animal models have failed to translate to successful efficacious medicines for Alzheimer's disease (AD) patients. While a wide variety of potential causes of these failures have been proposed,deficiencies in knowledge and best practices for translational research are not being sufficiently addressed by common training practices. Here we present proceedings from an annual NIA-sponsored workshop focused specifically on preclinical testing paradigms for AD translational research in animal models aimed at enabling improved preclinical to clinical translation for AD., (© 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)

Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summarises recent efforts to overcome these barriers in Europe. Two exemplar initiatives are described. The European Paediatric Translational Research Infrastructure facilitates preclinical research and other work that underpins clinical trials. conect4children facilitates the design and implementation of clinical trials. Both these initiatives listen to the voices of children and their advocates. Coordination of research needs specific effort that supplements work on science, resources and the policy context., (© 2020 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Biobanks play a central role in pediatric translational research, which deals primarily with genetic data from sample-based research. However, participation of children in biobanking has received only limited attention in the literature, even though research in general and in clinical trials in particular have a long history in involving minors. So, we resolved to explore specific challenging ethical, legal, and societal issues (ELSI) in the current pediatric biobanking landscape to propose a way forward for biobanking with children as partners in research. Methodologically, we first established the accessibility and utilization of pediatric biobanks, mainly in Europe. This was supported by a literature review related to children's participation, taking into account not only academic papers but also relevant guidelines and best-practices. Our findings are discussed under five themes: general vulnerability; ethical issues-balancing risks and benefits, right to an open future, return of results including secondary findings; legal issues-capacity and legal majority; societal issues-public awareness and empowerment; and responsible research with children. Ultimately, we observed an on-going shift from the parents'/guardians' consent being a sine-qua-non condition to the positive minor's agreement: confirming that the minor is the participant, not the parent(s)/guardian(s). This ethical rethinking is paving the way toward age-appropriate, dynamic and participatory models of involving minors in decision-making. However, we identified a requirement for dynamic tools to assess maturity, a lack of co-produced engagement tools and paucity of shared best practices. We highlight the need to provide empowerment and capability settings to support researchers and biobankers, and back this with practical examples. In conclusion, equipping children and adults with appropriate tools, and ensuring children's participation is at the forefront of responsible pediatric biobanking, is an ethical obligation, and a cornerstone for research integrity., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Casati, Ellul, Mayrhofer, Lavitrano, Caboux and Kozlakidis.)

Background: Gender disparities remain in the field of gastroenterology (GI) despite the decreasing gender gap in the medical field overall. We sought to examine primary and last female authorship as a marker of academic opportunity and advancement to assess the proportion of women publishing in GI over 20 years (1997-2017)., Methods: In this observational study, we assessed the gender and nationality of primary and last authors of original research manuscripts in three GI journals (Gastroenterology, Gut, and American Journal of Gastroenterology) across a 20-year period in 5-year intervals (in 1997, 2002, 2007, and 2012). We used a validated gender-determining algorithm, genderize.io, to classify gender. Our primary outcome was the proportion of female primary and last authors, with secondary measures assessing trends in gender and nationality., Results: Through the Genderize.io gender database, we were able to identify the gender for 3,673 (95.9%) of primary author names and 3,504 (95.4%) of last author names in the 3,615 manuscripts evaluated. Overall, there was a significant increase in female primary authors over time, from 18.1% in 1997 to 42.6% in 2017, a 6.0% increase per 5-year period (95% CI 4.8-7.2%). A similar trend was found for female last authors, however, at a slower rate, from 8.3% in 1997 to 24.7% in 2017, a 3.5% increase per 5 years (95% CI 2.5-4.4%). These trends were noted cumulatively, and in each journal individually. Manuscripts with a female last author were more likely to demonstrate a female primary author., Conclusion: Female authorship in high-impact gastroenterology journals has increased over time. Last authorship has lagged primary authorship in female representation and has increased more slowly over time. Interventions to reduce gender disparity in GI research should focus on the transition from first to last authorship., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Research Summit in Porto to discuss priorities and specific action points required for the successful implementation of the European Cancer Mission and Europe's Beating Cancer Plan (EBCP). Speakers presented a unified view about the need to establish high-quality, networked infrastructures to decrease cancer incidence, increase the cure rate, improve patient's survival and quality of life, and deal with research and care inequalities across the European Union (EU). These infrastructures, featuring Comprehensive Cancer Centres (CCCs) as key components, will integrate care, prevention and research across the entire cancer continuum to support the development of personalized/precision cancer medicine in Europe. The three pillars of the recommended European infrastructures - namely translational research, clinical/prevention trials and outcomes research - were pondered at length. Speakers addressing the future needs of translational research focused on the prospects of multiomics assisted preclinical research, progress in Molecular and Digital Pathology, immunotherapy, liquid biopsy and science data. The clinical/prevention trial session presented the requirements for next-generation, multicentric trials entailing unified strategies for patient stratification, imaging, and biospecimen acquisition and storage. The third session highlighted the need for establishing outcomes research infrastructures to cover primary prevention, early detection, clinical effectiveness of innovations, health-related quality-of-life assessment, survivorship research and health economics. An important outcome of the Summit was the presentation of the Porto Declaration, which called for a collective and committed action throughout Europe to develop the cancer research infrastructures indispensable for fostering innovation and decreasing inequalities within and between member states. Moreover, the Summit guidelines will assist decision making in the context of a unique EU-wide cancer initiative that, if expertly implemented, will decrease the cancer death toll and improve the quality of life of those confronted with cancer, and this is carried out at an affordable cost., (© 2021 The Authors. Molecular Oncology published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.)

Objective: Toolkits are an important knowledge translation strategy for implementing digital health. We studied how toolkits for the implementation and evaluation of digital health were developed, tested, and reported., Materials and Methods: We conducted a systematic review of toolkits that had been used, field tested or evaluated in practice, and published in the English language from 2009 to July 2019. We searched several electronic literature sources to identify both peer-reviewed and gray literature, and records were screened as per systematic review conventions., Results: Thirteen toolkits were eventually identified, all of which were developed in North America, Europe, or Australia. All reported their intended purpose, as well as their development process. Eight of the 13 toolkits involved a literature review, 3 did not, and 2 were unclear. Twelve reported an underlying conceptual framework, theory, or model: 3 cited the normalization process theory and 3 others cited the World Health Organization and International Telecommunication Union eHealth Strategy. Seven toolkits were reportedly evaluated, but details were unavailable. Forty-three toolkits were excluded for lack of field-testing., Discussion: Despite a plethora of published toolkits, few were tested, and even fewer were evaluated. Methodological rigor was of concern, as several did not include an underlying conceptual framework, literature review, or evaluation and refinement in real-world settings. Reporting was often inconsistent and unclear, and toolkits rarely reported being evaluated., Conclusion: Greater attention needs to be paid to rigor and reporting when developing, evaluating, and reporting toolkits for implementing and evaluating digital health so that they can effectively function as a knowledge translation strategy., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

National strategies to prevent sports injuries can potentially improve health outcomes at a population level and reduce medical costs. To date, a compilation of the strategies that countries have attempted, and their effectiveness, does not exist. This scoping review sets out to: identify nationwide attempts at implementing sports injury prevention strategies; examine the impact of these strategies; and map them onto the Translating Research into Injury Prevention Practice (TRIPP) framework. Using Levac's scoping review method, we: (a) identified the research questions, (b) identified relevant studies, (c) identified the study selection criteria, (d) charted the data, and (e) reported the results. A search of MEDLINE, Scopus, SPORTDiscus, CINAHL, and Web of Science databases for articles published pre-June 2019 was conducted. We identified 1794 studies and included 33 studies (of 24 strategies). The USA (n = 7), New Zealand (n = 4), Canada (n = 3), the Netherlands (n = 3), Switzerland (n = 2), Belgium (n = 1), France (n = 1), Ireland (n = 1), South Africa (n = 1), and Sweden (n = 1) have implemented nationwide sports injury prevention strategies with 29 (88%) of the included studies demonstrating positive results. Mapping the strategies onto the TRIPP framework highlighted that only four (17%) of the 24 included strategies reported on the implementation context (TRIPP Stage 5), suggesting an important reporting gap. Nationwide sports injury prevention efforts are complex, requiring a multidimensional approach. Future research should report intervention implementation data; examine the implementation context early in the research process to increase the likelihood of real-world implementation success; and could benefit from incorporating qualitative or mixed research methods., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Academic institutions are becoming more focused on translating new technologies for clinical applications. A transition from "bench to bedside" is often described to take basic research concepts and methods to develop a therapeutic or diagnostic solution with proven evidence of efficacy at the clinical level while also fulfilling regulatory requirements. The regulatory environment is evolving in Europe with transition and grace periods for the full enforcement of the Medical Device Regulation 2017/745 (MDR), replacing the Medical Device Directive 93/42/EEC (MDD). These new guidelines increase demands for scientific, technical, and clinical data with reduced capacity in regulatory bodies creating uncertainty in future product certification. Academic translational activities will be uniquely affected by this new legislation. The barriers and threats to successful translation in academia can be overcome by strong clinical partnerships, close-industrial collaborations, and entrepreneurial programs, enabling continued product development to overcome regulatory hurdles, reassuring their foothold of medical device development., (© 2020 Wiley-VCH GmbH.)

Malnutrition is highly prevalent in patients with foregut tumors comprising head and neck (HNC) and esophageal (EC) cancers, negatively impacting outcomes. International evidence-based guidelines (EBGs) for nutrition care exist; however, translation of research evidence into practice commonly presents considerable challenges and consequently lags. This study aimed to describe and evaluate current international nutrition care practices compared with the best-available evidence for patients with foregut tumors who are at high risk of malnutrition. A multi-centre prospective cohort study enrolled 170 patients commencing treatment of curative intent for HNC ( n = 119) or EC ( n = 51) in 11 cancer care settings in North America, Europe and Australia between 2016 and 2018. Adherence criteria were derived from relevant EBG recommendations with pooled results for participating centres reported according to the Nutrition Care Model at either system or patient levels. Adherence to EBG recommendations was: good (≥80%) for performing baseline nutrition screening and assessment, perioperative nutrition assessment and nutrition prescription for energy and protein targets; moderate (≥60 to 80%) for utilizing validated screening and assessment tools and pre-radiotherapy dietitian consultation; and poor (60%) for initiating post-operative nutrition support within 24 h and also dietetic consultation weekly during radiotherapy and fortnightly for 6 weeks post-radiotherapy. In conclusion, gaps in evidence-based cancer nutrition care remain; however, this may be improved by filling known evidence gaps through high-quality research with a concurrent evolution of EBGs to also encompass practical implementation guidance. These should aim to support multidisciplinary cancer clinicians to close evidence-practice gaps throughout the patient care trajectory with clearly defined roles and responsibilities that also address patient-reported concerns.

Background: TAK-063 is an inhibitor of phosphodiesterase 10A (PDE10A), an enzyme highly expressed in medium spiny neurons of the striatum. PDE10A hydrolyzes both cyclic adenosine monophosphate and cyclic guanosine monophosphate and modulates dopamine signaling downstream of receptor activation in both direct and indirect pathways of the striatum. TAK-063 exhibited antipsychotic-like effects in animal models; however, the translatability of these models to the clinical manifestations of schizophrenia and the meaningfulness for new targets such as PDE10A has not been established., Methods: The TAK-063 phase 1 program included a comprehensive translational development strategy with the main objective of determining whether the antipsychotic-like pharmacodynamic effects seen in nonclinical models would translate to human subjects. To evaluate this objective, we conducted a single-rising dose study (84 healthy subjects), a positron emission tomography (PET) study (12 healthy subjects), a functional magnetic resonance imaging blood oxygen level-dependent (BOLD) study (27 healthy subjects), and a multiple-rising dose study that included people with schizophrenia (30 healthy Japanese subjects and 47 subjects with stable schizophrenia). In addition, assessments of cognition and electroencephalography (27 healthy subjects and 47 subjects with stable schizophrenia) were included., Results: PDE10A engagement by TAK-063 was verified with a novel PET radiotracer for use in primates and humans. TAK-063 showed favorable pharmacokinetic and safety profiles in humans, and TAK-063 reduced ketamine-induced changes in electroencephalography and BOLD signaling in animal models and healthy human subjects. In addition, analogous effects on cognition were observed in animal models and human subjects., Conclusions: Overall, the phase 1 results showed some consistent evidence of antipsychotic activity. This translational strategy may be valuable for the future development of novel therapeutic approaches, even when relevant nonclinical models are not available., (© The Author(s) 2020. Published by Oxford University Press on behalf of CINP.)

The Drug Information Association (DIA) Europe 2020 brought together multiple stakeholders from around the world including regulatory agencies, industry, patients and academia, to discuss the most innovative topics in healthcare. Main subjects covered were regulatory science, data and data standards, clinical safety and pharmacovigilance, translational medicines and science, patient engagement in clinical development, value and access, medical affairs and scientific communication, health policy, and public affairs and legal issues. The meeting, which was initially intended to take place in Brussels, was finally held virtually due to the COVID-19 situation. This report covers some of the sessions held on these 5 days of state-of-the-art topic discussions., (Copyright 2020 Clarivate Analytics.)

The benefit of regular physical activity and exercise training for the prevention of cardiovascular and metabolic diseases is undisputed. Many molecular mechanisms mediating exercise effects have been deciphered. Personalised exercise prescription can help patients in achieving their individual greatest benefit from an exercise-based cardiovascular rehabilitation programme. Yet, we still struggle to provide truly personalised exercise prescriptions to our patients. In this position paper, we address novel basic and translational research concepts that can help us understand the principles underlying the inter-individual differences in the response to exercise, and identify early on who would most likely benefit from which exercise intervention. This includes hereditary, non-hereditary and sex-specific concepts. Recent insights have helped us to take on a more holistic view, integrating exercise-mediated molecular mechanisms with those influenced by metabolism and immunity. Unfortunately, while the outline is recognisable, many details are still lacking to turn the understanding of a concept into a roadmap ready to be used in clinical routine. This position paper therefore also investigates perspectives on how the advent of 'big data' and the use of animal models could help unravel inter-individual responses to exercise parameters and thus influence hypothesis-building for translational research in exercise-based cardiovascular rehabilitation.

A comprehensive translational cancer research approach focused on personalized and precision medicine, and covering the entire cancer research-care-prevention continuum has the potential to achieve in 2030 a 10-year cancer-specific survival for 75% of patients diagnosed in European Union (EU) member states with a well-developed healthcare system. Concerted actions across this continuum that spans from basic and preclinical research through clinical and prevention research to outcomes research, along with the establishment of interconnected high-quality infrastructures for translational research, clinical and prevention trials and outcomes research, will ensure that science-driven and social innovations benefit patients and individuals at risk across the EU. European infrastructures involving comprehensive cancer centres (CCCs) and CCC-like entities will provide researchers with access to the required critical mass of patients, biological materials and technological resources and can bridge research with healthcare systems. Here, we prioritize research areas to ensure a balanced research portfolio and provide recommendations for achieving key targets. Meeting these targets will require harmonization of EU and national priorities and policies, improved research coordination at the national, regional and EU level and increasingly efficient and flexible funding mechanisms. Long-term support by the EU and commitment of Member States to specialized schemes are also needed for the establishment and sustainability of trans-border infrastructures and networks. In addition to effectively engaging policymakers, all relevant stakeholders within the entire continuum should consensually inform policy through evidence-based advice., (© 2020 The Authors. Published by FEBS Press and John Wiley & Sons Ltd.)

We are far from reaching the sustainable development goals (SDGs) for health despite a wealth of novel insights in disease mechanisms and possible solutions. Why have we failed in knowledge translation and implementation? Starting from the case of cardiovascular diseases as one of the most prevalent non-communicable diseases, we examine barriers and hurdles, and perspectives for future health research. Health has multiple links with other SDGs. To accelerate the progress towards a healthy society, health research needs to take a broader view and become more cross-disciplinary and cross-sectoral. As one example, behavioural studies will underpin better prevention and treatment adherence. The next generation workforce in health and research needs an adapted education and training to implement more effective health approaches. As well, only effective dialogue and communication between researchers, practitioners, society and policymakers can lead to translation of evidence into policies, addressing the complexity of socioeconomic factors and commercial interests. Within Europe, health research needs a comprehensive vision and strategy that connects to achieving better health, as one of the interconnected SDGs., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Public Health Association.)

Clinical trials for rare neuromuscular diseases imply, among other investments, a high emotional burden for the whole disease community. Translation of data from preclinical studies to justify any clinical trial must be carefully pondered in order to minimize the risk of clinical trial withdrawal or failure. A rigorous distinction between proof-of-concept and preclinical efficacy studies using animal models is key to support the rationale of a clinical trial involving patients. This Review evaluates the experience accumulated by the TREAT-NMD Advisory Committee for Therapeutics, which provides detailed constructive feedback on clinical proposals for neuromuscular diseases submitted by researchers in both academia and industry, and emphasizes that a timely critical review of preclinical efficacy data from animal models, including biomarkers for specific diseases, combined with adherence to existing guidelines and standard protocols, can significantly help to de-risk clinical programs and prevent disappointments and costly engagement., Competing Interests: Competing interestsThe authors declare no competing or financial interests., (© 2020. Published by The Company of Biologists Ltd.)

Objective: The aim was to translate the findings of the QUASER study into a reflective, dialogic guide to help senior hospital leaders develop an organization wide QI strategy., Design: The QUASER study involved in depth ethnographic research into QI work and practices in two hospitals in each of five European countries. Three translational stakeholder workshops were held to review research findings and advise on the design of the Guide. An extended iterative process involving researchers from each participant country was then used to populate the Guide., Setting: The research was carried out in two hospitals in each of five European countries., Participants: In total, 389 interviews with healthcare practitioners and 803 hours of observations., Intervention: None., Main Outcome Measure: None., Results: The QUASER Hospital Guide was designed for leadership teams to diagnose their organization's strengths and weaknesses in the eight QI challenges. The Guide supports organizational dialogue about QI challenges, enables leaders to share perspectives, and helps teams to develop solutions to their situated problems. The Guide includes extensive examples of QI strategies drawn from the data and is published online and on paper., Conclusions: The QUASER Hospital Guide is empirically based, draws on a dialogical approach to Organizational Development and complexity science and can facilitate hospital leadership teams to identify the best solutions for their organization., (© The Author(s) 2019. Published by Oxford University Press in association with the International Society for Quality in Health Care.)

Fibrosis is a pivotal player in heart failure development and progression. Measurements of (markers of) fibrosis in tissue and blood may help to diagnose and risk stratify patients with heart failure, and its treatment may be effective in preventing heart failure and its progression. A lack of pathophysiological insights and uniform definitions has hampered the research in fibrosis and heart failure. The Translational Research Committee of the Heart Failure Association discussed several aspects of fibrosis in their workshop. Early insidious perturbations such as subclinical hypertension or inflammation may trigger first fibrotic events, while more dramatic triggers such as myocardial infarction and myocarditis give rise to full blown scar formation and ongoing fibrosis in diseased hearts. Aging itself is also associated with a cardiac phenotype that includes fibrosis. Fibrosis is an extremely heterogeneous phenomenon, as several stages of the fibrotic process exist, each with different fibrosis subtypes and a different composition of various cells and proteins - resulting in a very complex pathophysiology. As a result, detection of fibrosis, e.g. using current cardiac imaging modalities or plasma biomarkers, will detect only specific subforms of fibrosis, but cannot capture all aspects of the complex fibrotic process. Furthermore, several anti-fibrotic therapies are under investigation, but such therapies generally target aspecific aspects of the fibrotic process and suffer from a lack of precision. This review discusses the mechanisms and the caveats and proposes a roadmap for future research., (© 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Cancer Core Europe is a European legal alliance consisting of seven leading cancer centres - most of them Comprehensive Cancer Centres (CCCs) - with a single portal system to engage in various research projects with partners. Cancer Core Europe was established to create a sustainable, high-level, shared research infrastructure platform hosting research collaborations and task forces (data sharing, clinical trials, genomics, immunotherapy, imaging, education and training, and legal and ethical issues), with a controlled expansion agenda. Translational cancer research covers the cancer research continuum from basic to preclinical to early clinical, late clinical, and outcomes research. Basic-preclinical research serves as the 'engine' for early clinical research by bridging the early translational research gap and is the primary and current focus of the consortium as exemplified by the launching of the Basket of Baskets trial, Europe's largest precision cancer medicine trial. Inspired by the creation of Cancer Core Europe, the prevention community established Cancer Prevention Europe, a consortium of ten cancer prevention centres aimed at supporting the complete prevention research continuum. Presently, Cancer Core Europe and Cancer Prevention Europe are integrating therapeutics and prevention strategies to address in partnership the widening cancer problem. By providing innovative approaches for cancer research, links to healthcare systems, development of quality-assured multidisciplinary cancer care, and assessment of long-term outcomes, the virtual infrastructure will serve as a hub to connect and interact with other centres across Europe and beyond. Together, Cancer Core Europe and Cancer Prevention Europe are prepared to function as a central engine to tackle, in collaboration with various partners, a potential 'mission on cancer' addressing the cancer burden., (© 2019 The Authors. Published by FEBS Press and John Wiley & Sons Ltd.)

Today, cancer is a significant challenge for society, healthcare systems and the growing number of affected patients and their families. This article argues that new paradigms and conditions for responsible science and innovation policy across the European Union (EU) require (i) the collective action of Research & Development institutions, (ii) a system approach to health systems, higher education and patient organizations, and (iii) new initiatives to encourage international cooperation across an enlarged Europe; no single country can successfully fight the disease(s) on its own. Recently, a cancer mission was proposed (Celis and Pavalski, ), the origins of which are rooted in the continuous efforts of the research community, cancer patient organizations, member states and the European Commission during nearly two decades to address the fragmentation and lack of coordination of European cancer research; these efforts led to the creation of Cancer Core Europe and Cancer Prevention Europe, consortia aimed at linking therapeutic and prevention geometries. Ultimately, the platform/infrastructure will be composed of networks of Comprehensive Cancer Centres and cancer research centres across Europe to reach the critical mass of expertise, patients and collaborative portfolio of projects that are necessary to promote science-driven and social innovations in the era of personalized (precision) cancer medicine. Employing a mission-oriented approach to achieve the goal of ensuring a long life expectancy for three out of four cancer patients by 2030 is likely to have a particularly positive impact on the way European citizens' value science and knowledge. It will change the lives of many families across Europe and beyond and should be oriented to ensure that Europe is at the forefront when it comes to quality of life. It is our collective responsibility to ensure that not a single person or region in Europe is left behind., (© 2019 The Authors. Published by FEBS Press and John Wiley & Sons Ltd.)

Written by associate editors of the Annals of Nuclear Medicine, this invited review article is intended to offer our readers a condensed global view on the high-quality research work that has been published in Europe last year. We have divided this article into five sections. The first three sections from the oncology category include "[ 18 F]fluorodeoxyglucose (FDG) positron-emission tomography (PET) for therapy monitoring in malignant lymphoma", "[ 18 F]fluoromisonidazole (FMISO) PET for hypoxia", and "lymphoscintigraphy update". It is followed by a section on "amyloid PET for Alzheimer's disease" using [ 11 C]Pittsburgh Compound B (PiB) and [ 18 F]florbetapir from the neurology category. The final section reviews three original articles in the field of "basic and translational molecular imaging" regardless of the category, which investigated new PET tracers such as L-4-borono-2-[ 18 F]fluoro-phenylalanine (FBPA), O-(2-[ 18 F]fluoroethyl)-L-tyrosine (FET) and 64 Cu-NOTA-pertuzumab in small animals. We hope that this review article will arouse greater interest in our readers in recent European research trends in the field of nuclear medicine.

The European Academy of Cancer Sciences (EACS) is an independent advisory body of well-recognised medical specialists and researchers striving to create a compelling interactive continuum of cancer research, from innovative basic research to implementation of state-of-the-art evidence-based cancer care and prevention. Achieving the above will entail bridging high-quality basic and preclinical cancer research to research on prevention, early detection and therapeutics as well as improving coordination of translational research efforts across Europe. The latter is expected to be expedited through quality assuring translational cancer research in Comprehensive Cancer Centres - entities that link research with the healthcare system - and networks of cancer research centres. Achieving a critical mass of expertise, resources and patients is crucial. Improving late translational research, which involves clinical studies to assess effectiveness, and added value for the health care is also a high priority. Both high-quality Big Data collections and the intelligent use of these data will promote innovation in cancer research and support outcomes research to assess clinical utility, quality of cancer care and long-term follow-up of treated patients. The EACS supports the mission-oriented approach recently proposed by the European Commission in Horizon Europe to deal with major challenges and would like to persuade the EU and its member states to formally launch a mission in cancer to boost and streamline the cancer research continuum in Europe. Building a coherent translational cancer research continuum with a focus on patients and individuals at risk will require, however, foresight as well as the extensive and continuous provision of evidence-based advice to inform policy., (© 2018 The Authors. Published by FEBS Press and John Wiley & Sons Ltd.)

Objective: To provide a systematic evaluation of the broad clinical variability in Friedreich ataxia (FRDA), a multisystem disorder presenting mainly with afferent ataxia but also a complex phenotype of nonataxia symptoms., Methods: From the large database of the European Friedreich's Ataxia Consortium for Translational Studies, 650 patients with genetically confirmed FRDA were included. Detailed data of medical history documentation, questionnaires, and reports on clinical features were analyzed to provide in-depth description of the clinical profile and frequency rates of phenotypical features with a focus on differences between typical-onset and late-onset FRDA. Logistic regression modeling was used to identify predictors for the presence of the most common clinical features., Results: The most frequent clinical features beyond afferent ataxia were abnormal eye movements (90.5%), scoliosis (73.5%), deformities of the feet (58.8%), urinary dysfunction (42.8%), cardiomyopathy and cardiac hypertrophy (40.3%), followed by decreased visual acuity (36.8%); less frequent features were, among others, depression (14.1%) and diabetes (7.1%). Most of these features were more common in the typical-onset group compared to the late-onset group. Logistic regression models for the presence of these symptoms demonstrated the predictive value of GAA repeat length on the shorter allele and age at onset, but also severity of ataxia signs, sex, and presence of neonatal problems., Conclusions: This joint European effort demonstrates the multisystem nature of this neurodegenerative disease encompassing most the central nervous, neuromuscular, cardiologic, and sensory systems. A distinct and deeper knowledge of this rare and chronic disease is highly relevant for clinical practice and designs of clinical trials., (© 2018 American Academy of Neurology.)

Background: In evidence-informed policy-making (EIP), major knowledge gaps remain in understanding the context and possibilities for institutionalisation of knowledge translation. In 2014, the WHO Evidence-informed Policy Network (EVIPNet) Europe initiated a number of pilot countries, with Hungary among them, to engage in a 'situation analysis' (SA) in order to fill some of those gaps. This contribution discusses the results of the SA in Hungary on research-policy interactions, facilitating factors and potential barriers to establish a knowledge translation platform (KTP)., Methods: In line with the EVIPNet Europe SA Manual, a document analysis, 13 interviews, 3 focus group discussions with 21 participants, and an online survey with 31 respondents were carried out from April to October, 2015. A SA aims to assess the context in which EIP takes form and seeks opportunities to establish a KTP, so information was gathered on the current practice of EIP and knowledge translation, its relevant actors, enablers and barriers for EIP, and opinions on a future KTP. Methodological and researcher triangulation resulted in a narrative synthesis of data, including a comparison with literature. A stakeholder consultation was organised to validate findings., Results: This study reveals that stakeholders show commitment to produce and use research evidence in Hungarian health policy-making. All stakeholders endorsed the idea of strengthening the systematic use of evidence in decision-making and favoured the idea of establishing a KTP. In line with literature on other countries, some good practices exist on the uptake of evidence in policy-making; however, a systematic approach of developing, translating and using research evidence in health policy processes is lacking. EIP is currently hampered by scattered capacity, coordination problems, high fluctuation in government, an often legalistic and a more 'symbolic' rather than practical support for knowledge translation and EIP. The article summarises recommendations on a Hungarian KTP., Conclusions: Pragmatic adaptation of the SA Manual to local needs proved to be a useful mechanism to provide insight into the Hungarian EIP field and the establishment of a potential KTP. Despite the success of a KTP pilot, it remains unclear how a KTP in Hungary will be institutionalised in a sustainable way.

Background: Ensuring health policies are informed by evidence still remains a challenge despite efforts devoted to this aim. Several tools and approaches aimed at fostering evidence-informed policy-making (EIPM) have been developed, yet there is a lack of availability of indicators specifically devoted to assess and support EIPM. The present study aims to overcome this by building a set of measurable indicators for EIPM intended to infer if and to what extent health-related policies are, or are expected to be, evidence-informed for the purposes of policy planning as well as formative and summative evaluations., Methods: The indicators for EIPM were developed and validated at international level by means of a two-round internet-based Delphi study conducted within the European project 'REsearch into POlicy to enhance Physical Activity' (REPOPA). A total of 82 researchers and policy-makers from the six European countries (Denmark, Finland, Italy, the Netherlands, Romania, the United Kingdom) involved in the project and international organisations were asked to evaluate the relevance and feasibility of an initial set of 23 indicators developed by REPOPA researchers on the basis of literature and knowledge gathered from the previous phases of the project, and to propose new indicators., Results: The first Delphi round led to the validation of 14 initial indicators and to the development of 8 additional indicators based on panellists' suggestions; the second round led to the validation of a further 11 indicators, including 6 proposed by panellists, and to the rejection of 6 indicators. A total of 25 indicators were validated, covering EIPM issues related to human resources, documentation, participation and monitoring, and stressing different levels of knowledge exchange and involvement of researchers and other stakeholders in policy development and evaluation., Conclusion: The study overcame the lack of availability of indicators to assess if and to what extent policies are realised in an evidence-informed manner thanks to the active contribution of researchers and policy-makers. These indicators are intended to become a shared resource usable by policy-makers, researchers and other stakeholders, with a crucial impact on fostering the development of policies informed by evidence.

Background: It is widely accepted that research can lead to improved health outcomes. However, translating research into meaningful impacts in peoples' lives requires actions that stretch well beyond those traditionally associated with knowledge creation. The research reported in this manuscript provides an international review of health research funders' efforts to encourage this process of research uptake, application and scaling, often referred to as knowledge translation., Methods: We conducted web-site review, document review and key informant interviews to investigate knowledge translation at 26 research funding agencies. The sample comprises the regions of Australia, Europe and North America, and a diverse range of funder types, including biomedical, clinical, multi-health domain, philanthropic, public and private organisations. The data builds on a 2008 study by the authors with the same international sample, which permitted longitudinal trend analysis., Results: Knowledge translation is an objective of growing significance for funders across each region studied. However, there is no clear international consensus or standard on how funders might support knowledge translation. We found that approaches and mechanisms vary across region and funder type. Strategically tailored funding opportunities (grants) are the most prevalent modality of support. The most common funder-driven strategy for knowledge translation within these grants is the linking of researchers to research users. Funders could not to provide empirical evidence to support the majority of the knowledge translation activities they encourage or undertake., Conclusions: Knowledge translation at a research funder relies on context. Accordingly, we suggest that the diversity of approaches uncovered in our research is fitting. We argue that evaluation of funding agency efforts to promote and/or support knowledge translation should be prioritised and actioned. It is paradoxical that funders' efforts to get evidence into practice are not themselves evidence based.

For over 50years the European Organization for Research and Treatment of Cancer (EORTC) has delivered major advances in cancer clinical research and cancer therapeutics. The introduction of molecularly targeted agents has led to significant improvements in outcome for patients with specific tumor types; however conventional chemotherapy remains the mainstay of treatment for the majority of patients. Due to increasing knowledge about the diversity of molecular pathways driving malignant progression, strategies to integrate biology into clinical research and development are continuously evolving. The challenges and the experience of the EORTC regarding how translational research is to be an indispensable component of the clinical research environment, which aims to deliver more sophisticated treatment approaches will be discussed in this perspective article., (Copyright © 2017 National Cancer Institute, Cairo University. Production and hosting by Elsevier B.V. All rights reserved.)

Asthma, rhinitis, and eczema are complex diseases with multiple genetic and environmental factors interlinked through IgE-associated and non-IgE-associated mechanisms. Mechanisms of the Development of ALLergy (MeDALL; EU FP7-CP-IP; project no: 261357; 2010-2015) studied the complex links of allergic diseases at the clinical and mechanistic levels by linking epidemiologic, clinical, and mechanistic research, including in vivo and in vitro models. MeDALL integrated 14 European birth cohorts, including 44,010 participants and 160 cohort follow-ups between pregnancy and age 20 years. Thirteen thousand children were prospectively followed after puberty by using a newly standardized MeDALL Core Questionnaire. A microarray developed for allergen molecules with increased IgE sensitivity was obtained for 3,292 children. Estimates of air pollution exposure from previous studies were available for 10,000 children. Omics data included those from historical genome-wide association studies (23,000 children) and DNA methylation (2,173), targeted multiplex biomarker (1,427), and transcriptomic (723) studies. Using classical epidemiology and machine-learning methods in 16,147 children aged 4 years and 11,080 children aged 8 years, MeDALL showed the multimorbidity of eczema, rhinitis, and asthma and estimated that only 38% of multimorbidity was attributable to IgE sensitization. MeDALL has proposed a new vision of multimorbidity independent of IgE sensitization, and has shown that monosensitization and polysensitization represent 2 distinct phenotypes. The translational component of MeDALL is shown by the identification of a novel allergic phenotype characterized by polysensitization and multimorbidity, which is associated with the frequency, persistence, and severity of allergic symptoms. The results of MeDALL will help integrate personalized, predictive, preventative, and participatory approaches in allergic diseases., (Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Compelling evidence has been accumulated to support the effectiveness of intensive lifestyle intervention in delaying progression to Type 2 diabetes even in people identified as being at high risk determined by the Finnish diabetes risk score. The DE-PLAN-CAT project (diabetes in Europe-prevention using lifestyle, physical activity and nutritional intervention-Catalonia) evidenced that intensive lifestyle intervention was feasible and cost-effective on a short scale in real-life primary care settings, at least over 4 years. However, transferring such lifestyle interventions to society remains the major challenge of research in the field of diabetes prevention., Methods/design: The derived DP-TRANSFERS (diabetes prevention-transferring findings from European research to society) is a large scale national programme aimed at translating a tailored lifestyle intervention to the maximum of primary care centres where feasible through a core proposal agreed with all the partners. The method is built upon a 3-step (screening, intervention and follow-up) real-life, community-wide structure on the basis of a dual intensity lifestyle intervention (basic and continuity modules) and supported by a 4-channel transfer strategy (institutional relationships, facilitators' workshops, collaborative groupware and programme WEB page). Participation will initially cover nine health departments (7 million inhabitants) through nine coordinating centres located in metropolitan (3.2 million), semi-urban (2.9 million) and rural (0.9 million) areas from which it is expected accessing 25 % of all primary care settings, equivalent to 90 associated centres (1.6-1.8 million people) with an estimate of 0.32 million participants aged 45-75 years at high risk of future development of diabetes. To ascertain sustainability, effect, satisfaction and quality of the translation programme statistical analyses will be performed from both the entire population (facilitators and participants) and a stratified representative sample obtained by collecting data from at least 920 participants., Discussion: The DP-TRANSFERS will use a strategy of approach to society consistent with the impact of the disease and the fast accessibility provided by primary care settings in Catalonia. Both the widespread effect of the lifestyle intervention and the translational process itself could be assessed.

Vertigo is one of the most common complaints in medicine. Despite its high prevalence, patients with vertigo often receive either inappropriate or inadequate treatment. The most important reasons for this deplorable situation are insufficient interdisciplinary cooperation, nonexistent standards in diagnostics and therapy, the relatively rare translations of basic science findings to clinical applications, and the scarcity of prospective controlled multicenter clinical trials. To overcome these problems, the German Center for Vertigo and Balance Disorders (DSGZ) started an initiative to establish a European Network for Vertigo and Balance Research called DIZZYNET. The central aim is to create a platform for collaboration and exchange among scientists, physicians, technicians, and physiotherapists in the fields of basic and translational research, clinical management, clinical trials, rehabilitation, and epidemiology. The network will also promote public awareness and help establish educational standards in the field. The DIZZYNET has the following objectives as regards structure and content: to focus on multidisciplinary translational research in vertigo and balance disorders, to develop interdisciplinary longitudinal and transversal networks for patient care by standardizing and personalizing the management of patients, to increase methodological competence by implementing common standards of practice and quality management, to internationalize the infrastructure for prospective multicenter clinical trials, to increase recruitment capacity for clinical trials, to create a common data base for patients with vertigo and balance disorders, to offer and promote attractive educational and career paths in a network of cooperating institutions. In the long term, the DIZZYNET should serve as an internationally visible network for interdisciplinary and multiprofessional research on vertigo and balance disorders. It ideally should equally attract the afflicted patients and those managing their disorders. DIZZYNET will not compete with the traditional national or international societies active in the field, but will function as an additional structure that addresses some of the above problems.

Background: Dissemination bias occurs when only some results emerging from clinical research reach their intended audience in the knowledge translation process. Given that coverage decisions increasingly rely on evidence, it is important to explore the types of evidence considered. This paper aimed to examine the evidence base used by regulatory institutions involved in pricing and reimbursement of pharmaceuticals in a broad range of European countries, as well as their awareness of and approach towards dissemination bias., Methods: A mixed methods approach was adopted. Regulatory documents and published literature were identified in systematic searches and relevant documents were analysed. An online survey was carried out to verify and expand insights., Results: Forty-two relevant regulatory documents and 10 publications were included. The survey had a 35% response rate, yielding valid responses for 13 countries. A fragmented impression was obtained for most countries indicating a general lack of transparency regarding both processes of decision-making and approaches towards unpublished information. Dissemination bias was rarely consistently considered. Practices for the identification and inclusion of all available evidence varied considerably, as did the influence of missing evidence on decision-making. Differences were often attributable to the regulatory context and/or institutional principles., Conclusions: Best practice is difficult to generalize given the identified variations. Individual exemplary practices support the necessity for institutional exchange at international level. Increased institutional commitment to transparency of methods and processes should be advocated.

A collaborative consortium, named "TRANSAUTOPHAGY," has been created among European research groups, comprising more than 150 scientists from 21 countries studying diverse branches of basic and translational autophagy. The consortium was approved in the framework of the Horizon 2020 Program in November 2015 as a COST Action of the European Union (COST means: CO-operation in Science and Technology), and will be sponsored for 4 years. TRANSAUTOPHAGY will form an interdisciplinary platform for basic and translational researchers, enterprises and stakeholders of diverse disciplines (including nanotechnology, bioinformatics, physics, chemistry, biology and various medical disciplines). TRANSAUTOPHAGY will establish 5 different thematic working groups, formulated to cooperate in research projects, share ideas, and results through workshops, meetings and short term exchanges of personnel (among other initiatives). TRANSAUTOPHAGY aims to generate breakthrough multidisciplinary knowledge about autophagy regulation, and to boost translation of this knowledge into biomedical and biotechnological applications.

Although Europe 'produces' excellent science, it has not been equally successful in translating scientific results into commercially successful companies in spite of European and national efforts invested in supporting the translation process. The Idea-to-Market process is highly complex due to the large number of actors and stakeholders. ITECH was launched to propose recommendations which would accelerate the Idea-to-Market process of health technologies leading to improvements in the competitiveness of the European health technology industry in the global markets. The project went through the following steps: defining the Idea-to-Market process model; collection and analysis of funding opportunities; identification of 12 gaps and barriers in the Idea-to-Market process; a detailed analysis of these supported by interviews; a prioritization process to select the most important issues; construction of roadmaps for the prioritized issues; and finally generating recommendations and associated action plans. Seven issues were classified as in need of actions. Three of these are part of the ongoing Medical Device Directive Reform (MDR), namely health technology assessment, post-market surveillance and regulatory process, and therefore not within the scope of ITECH. Recommendations were made for eHealth taxonomy; Education and training; Clinical trials and Adoption space and Human Factors Engineering (HFE).

To understand the meaning of the term Systems Medicine and to distinguish it from seemingly related other expressions currently in use, such as precision, personalized, -omics, or big data medicine, its underlying history and development into present time needs to be highlighted. Having this development in mind, it becomes evident that Systems Medicine is a genuine concept as well as a novel way of tackling the manifold complexity that occurs in nowadays clinical medicine-and not just a rebranding of what has previously been done in the past. So looking back it seems clear to many in the field that Systems Medicine has its origin in an integrative method to unravel biocomplexity, namely, Systems Biology. Here scientist by now gained useful experience that is on the verge toward implementation in clinical research and practice.Systems Medicine and Systems Biology have the same underlying theoretical principle in systems-based thinking-a methodology to understand complexity that can be traced back to ancient Greece. During the last decade, however, and due to a rapid methodological development in the life sciences and computing/IT technologies, Systems Biology has evolved from a scientific concept into an independent discipline most competent to tackle key questions of biocomplexity-with the potential to transform medicine and how it will be practiced in the future. To understand this process in more detail, the following section will thus give a short summary of the foundation of systems-based thinking and the different developmental stages including systems theory, the development of modern Systems Biology, and its transition into clinical practice. These are the components to pave the way toward Systems Medicine.

In Germany, approximately half a million people suffer from cancer pain, which is one of the most common first symptoms of tumor disease in 20-40% of the patients. The prevalence increases during the course of the disease to approximately 90% among patients in a palliative care unit. Treatment in the field of cancer pain is often provided by interdisciplinary teams of different pain or palliative care services. Due to the high availability of opioids and also, in European comparison, of a high number of specialized services in hospice and palliative care provision, Germany plays a special role next to Great Britain. There is a great need for the further development of the coordination and networking of these services within Germany, which is regulated by the Hospice and Palliative Act. The cross-sectional curricula QB 13 (palliative medicine) and QB 14 (pain medicine) were implemented in German medical faculties in order to improve integration of cancer pain management into the teaching of medical students. Research in the area of cancer pain addresses clinical topics such as the availability of opioids, but also basic research including genetic variability as a predictor for the efficacy of opioids and the neurobiology of cancer pain.

Background: Coverage decisions determining the benefit baskets of health systems have been increasingly relying on evidence regarding patient benefit and costs. Relevant structures, methodologies, and processes have especially been established for pharmaceuticals but approaches differ. The objective of this work was thus to identify institutions in a broad range of European countries (n = 36) in charge of determining the value of pharmaceuticals for pricing and reimbursement purposes and to map their decision-making process; to examine the different approaches and consider national and supranational possibilities for best practice., Methods: Institutions were identified through websites of international networks, ministries, and published literature. Details on institutional practices were supplemented with information from institution websites and linked online sources., Results: The type and extent of information available varied considerably across countries. Different types of public regulatory bodies are involved in pharmaceutical coverage decisions, assuming a range of responsibilities. As a rule, the assessment of scientific evidence is kept structurally separate from its appraisal. Recommendations on value are uniformly issued by specific committees within or commissioned by responsible institutions; these institutions often also act as decision-makers on reimbursement status and level or market price. While effectiveness and costs are important criteria in all countries, the latter are often considered on a case-by-case basis. In all countries, manufacturer applications, including relevant evidence, are used as one of the main sources of information for the assessment., Conclusion: Transparency of evidence-based coverage decisions should be enhanced. International collaboration can facilitate knowledge exchange, improve efficiency of information production, and strengthen new or developing systems.

Background: Multimorbidity, according to the World Health Organization, exists when there are two or more chronic conditions in one patient. This definition seems inaccurate for the holistic approach to Family Medicine (FM) and long-term care. To avoid this pitfall the European General Practitioners Research Network (EGPRN) designed a comprehensive definition of multimorbidity using a systematic literature review., Objective: To translate that English definition into European languages and to validate the semantic, conceptual and cultural homogeneity of the translations for further research., Method: Forward translation of the EGPRN's definition of multimorbidity followed by a Delphi consensus procedure assessment, a backward translation and a cultural check with all teams to ensure the homogeneity of the translations in their national context. Consensus was defined as 70% of the scores being higher than 6. Delphi rounds were repeated in each country until a consensus was reached., Results: 229 European medical expert FPs participated in the study. Ten consensual translations of the EGPRN comprehensive definition of multimorbidity were achieved., Conclusion: A comprehensive definition of multimorbidity is now available in English and ten European languages for further collaborative research in FM and long-term care.

Unlabelled: The Learning Health System (LHS) describes linking routine healthcare systems directly with both research translation and knowledge translation as an extension of the evidence-based medicine paradigm, taking advantage of the ubiquitous use of electronic health record (EHR) systems. TRANSFoRm is an EU FP7 project that seeks to develop an infrastructure for the LHS in European primary care., Methods: The project is based on three clinical use cases, a genotype-phenotype study in diabetes, a randomised controlled trial with gastroesophageal reflux disease, and a diagnostic decision support system for chest pain, abdominal pain, and shortness of breath., Results: Four models were developed (clinical research, clinical data, provenance, and diagnosis) that form the basis of the projects approach to interoperability. These models are maintained as ontologies with binding of terms to define precise data elements. CDISC ODM and SDM standards are extended using an archetype approach to enable a two-level model of individual data elements, representing both research content and clinical content. Separate configurations of the TRANSFoRm tools serve each use case., Conclusions: The project has been successful in using ontologies and archetypes to develop a highly flexible solution to the problem of heterogeneity of data sources presented by the LHS.

The European Institute of Oncology began the process to reach the accreditation promoted by the Organisation of European Cancer Institutes (OECI) in 2012. This accreditation integrates the quality and safety path started in 2001 with accreditation by the Joint Commission International. Despite the presence of diversified accreditations and certifications and the clear need of time, effort, and commitment, the models are complementary. Each model is not to be considered as an end but as a tool for improvement: e.g., mixing accreditation standards led to an improvement in the quality and safety of processes. The present article details the OECI accreditation experience of the European Institute of Oncology, in particular the following strengths of OECI standards: collaboration among several involved parties (patient, volunteer, patient's general practitioner) in the clinical and quality/safety processes; a larger involvement of support personnel (psycho-oncologists, dieticians, physical therapists); and the development of clinical/translational research and innovation in prevention, diagnosis, and treatment to guarantee the best available practice in diagnosis and treatment. The OECI accreditation is specific to oncology and therefore its standards are tailored to a cancer center, both in terms of language used in the standards manual and in terms of patient needs. The OECI accreditation system puts an auditor team with a standards manual in charge of verifying quality and confirms the definition of IEO as a Comprehensive Cancer Center.

In this study, we explore and discuss nanoparticles and nanoscale materials and their use in medicine (nanomedicine) and pharmaceutics (nanopharmaceutics). The study is aimed at shedding light on this highly multidisciplinary research field and at examining the influence of research funding, industrial applications, and legal and regulatory frameworks on the research in this field, a clear understanding of which is essential to efficiently support the translation of research findings into industrial and clinical applications and to enable access to a larger society.