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The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of ongoing studies were issued; however, national coordination is still lacking. This article aims to raise awareness on the struggle of managing ongoing clinical trials in the EU during the pandemic. The goals are to bring attention, from a legal and regulatory point of view to the difficulties faced by those involved in clinical research, and to critically position the current hurdles against the backdrop of the existing legal and ethical framework. We investigated the EU guidance and the national approaches of all EU/EEA Member States, and critically discussed selected issues. We argue that the crisis may be an opportunity to foresee meaningful changes in the EU clinical trials framework post-COVID-19. ispartof: European Journal of Health Law vol:27 issue:5 pages:425-450 ispartof: location:Netherlands status: published

This chapter seeks to provide an insight into how the regulatory discretion the GDPR has left to the Member States has been used. It reviews the biobank regulatory environment; whether and how derogations under Article 89(2) GDPR are enabled; the legal basis for scientifc research and role of consent in biobanking post-GDPR; the balance between individual rights and public interest in national law; and fnally, the GDPR’s impact and future possibilities for biobanking. While in exercising their national self-determination the Member States have some possibility to tailor data protection requirements corresponding to their values and aspirations, it risks coming with implications, jeopardizing collaborative research. At this point, it could be argued that Research Ethics Committees (RECs) may have a considerable role to play in navigating the gap between the legal and ethical requirements in both a national as well as a cross-border context.

This contribution aims to present in a clear and concise manner the intricate legal framework for biobank research in Belgium. In Part 1, we describe the Belgian biobank infrastructure, with a focus on the concept of biobank. In Part 2, we provide an overview of the applicable legal framework, namely the Act of 19 December 2008 on Human Body Material (HBM), and its amendments. Attention is given to an essential piece of self-regulation, namely the Compendium on biobanks issued by the Federal Agency on Medicine Products and Health (FAMPH). Furthermore, we delineate the interplay with relevant data protection rules. Part 3 is dedicated to the main research oversight bodies in the field of biobanking. In Part 4, we provides several examples of the ‘law in context’. In particular, we discuss issues pertaining to presumed consent, processing of personal data associated with HBM, and information provided to the donor of HBM. Finally, Part 5 and 6 addresses the impact of the EU General Data Protection Regulation (GDPR), suggests lines for further research, and outline the future possibilities for biobanking in Belgium.

At the time of mayor breakthroughs in knowledge of molecular biology leading to change in design and conduct of innovative clinical research, there is a clear need for optimal co-operation at the EU level as well as with each Member States. The current legal framework for health research is developed and revised by several DGs dealing with clinical trials, data protection, in-vitro diagnostic tests and biomarkers. Also medical devices and advanced therapy directive / regulation have to be taken into consideration, all within a single trial/study. Such fragmentation of legal framework and national laws lead to several inconsistencies, wasting time and scarce resources of sponsors, whether academic or pharmaceutical industry and all involved parties are facing the complexity of current clinical research. Could we consider a single stop-shop for such initiative? Competitivity of European research is at stake and comprehensive coordination between all partners is crucial for the benefit of European citizens.

Objectives The Gynecologic Cancer InterGroup (GCIG) is a global consortium consisting of research groups from various countries to facilitate collaboration in clinical trials in gynecologic cancer; founded in 1993 and formalized in 1997. Global clinical trials often have multiple obstacles for operating them. To address such issues, the GCIG established a Harmonization Operations Committee in 2003. Achievements of this Harmonization committee are summarized. Methods Minutes of GCIG meetings between 2004 and 2017 were reviewed. Participating member groups and Harmonization activities were summarized. Results The average numbers of participant groups were 10.8 from 2004 to 2008, 17.0 from 2009 to 2013, and 19.1 from 2014 to 2017. The participant groups originated from Europe, North America, Latin America, Oceania and Asia. Total number of activities was 69. The major activities were aimed at overcoming international variations in managing clinical trials (eg. budgeting, insurance, data quality, communication amongst groups, etc.). The committee developed common templates, tools and policies, as well as minimum standards of data quality for GCIG trials, in order to facilitate intergroup collaboration. The committee also addressed issues in rare tumors, translational research and QoL/PRO instruments. Education, including mentoring, is ongoing. Conclusions With growing recognition of the importance of operational harmonization in international trials, more groups have been participating in the Harmonization Committee. The committee has been challenging problems towards improving outcomes for patients. This review showed that operational harmonization is an essential component of successful international trials. The Harmonization Committee will continue to enhance high quality clinical trials for gynecologic cancer patients.

Background Type 1 diabetes (T1D) is a chronic condition in which the pancreas loses the ability to produce insulin due to an autoimmune destruction of the insulin producing beta cells in the pancreatic islets of Langerhans. Pathophysiological complications related to diabetes include micro and macrovascular disease, nephropathy, and neuropathy that can also be affected by environmental factors such as lifestyle and diet. Objectives The current study aimed to evaluate the serum levels of total copper, the copper-carrying protein, ceruloplasmin and nonceruloplasmin bound copper (nonceruloplasmin-Cu) and other essential and environmental metals and metalloids in subjects with T1D compared with healthy controls. Methods A cohort of 63 subjects with T1D attending Diabetes Clinics at the University of Miami and 65 healthy control subjects was studied. Metals and metalloids were measured by inductively coupled plasma mass spectrometry. Results A main finding of this study was that total copper and ceruloplasmin levels were higher in persons with T1D compared to healthy controls. In comparison to other metals and clinical variables, elevated copper was the strongest factor associated with T1D resulting in a15-fold increased odds of having the disease per standard deviation increase. Conclusion Our results suggest a metal and metalloid perturbation in T1D with a significant involvement of Copper dysfunction in the disease pathology, possibly linked to inflammatory processes.

In the era of personalized medicine, the introduction of translational studies in clinical trials has substantially increased their costs, but provides the possibility of improving the productivity of trials with a better selection of recruited patients. With the overall goal of creating a roadmap to improve translational design for future gynecological cancer trials and of defining translational goals, a main discussion was held during a brainstorming day of the Gynecologic Cancer InterGroup (GCIG) Translational Research Committee and overall conclusions are here reported. A particular emphasis was dedicated to the new frontier of the immunoprofiling of gynecological cancers. The discussion pointed out that to maximize patients’ benefit, translational studies should be integral to clinical trial design with standardization and optimization of procedures including a harmonization program of Standard Operating Procedures. Pathology-reviewed sample collection should be mandatory and ensured by dedicated funding. Biomarker validation and development should be made public and transparent to ensure rapid progresses with positive outcomes for patients. Guidelines/templates for patients’ informed consent are needed. Importantly for the public, recognized goals are to increase the involvement of advocates and to improve the reporting of translational data in a forum accessible to patients.

Background: ECCO essential requirements for quality cancer care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to patients who have a specific tumour type. They are written by European experts representing all disciplines involved in cancer care. ERQCC papers give oncology teams, patients, policymakers and managers an overview of the elements needed in any healthcare system to provide high quality of care throughout the patient journey. References are made to clinical guidelines and other resources where appropriate, and the focus is on care in Europe. Colorectal cancer: essential requirements for quality care Colorectal cancer (CRC) is the second most common cause of cancer death in Europe and has wide variation in outcomes among countries. Increasing numbers of older people are contracting the disease, and treatments for advanced stages are becoming more complex. A growing number of survivors also require specialist support. High-quality care can only be a carried out in specialised CRC units or centres which have both a core multidisciplinary team and an extended team of allied professionals, and which are subject to quality and audit procedures. Such units or centres are far from universal in all European countries. It is essential that, to meet European aspirations for comprehensive cancer control, healthcare organisations implement the essential requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship. Conclusion: Taken together, the information presented in this paper provides a comprehensive description of the essential requirements for establishing a high-quality CRC service. The ECCO expert group is aware that it is not possible to propose a 'one size fits all' system for all countries, but urges that access to multidisciplinary units or centres must be guaranteed for all those with CRC. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.

Background: ECCO essential requirements for quality cancer care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to patients who have a specific tumour type. They are written by European experts representing all disciplines involved in cancer care. ERQCC papers give oncology teams, patients, policymakers and managers an overview of the elements needed in any healthcare system to provide high quality of care throughout the patient journey. References are made to clinical guidelines and other resources where appropriate, and the focus is on care in Europe. Sarcoma: essential requirements for quality care Sarcomas - which can be classified into soft tissue and bone sarcomas - are rare, but all rare cancers make up more than 20% of cancers in Europe, and there are substantial inequalities in access to high-quality care. Sarcomas, of which there are many subtypes, comprise a particularly complex and demanding challenge for healthcare systems and providers. This paper presents essential requirements for quality cancer care of soft tissue sarcomas in adults and bone sarcomas. High-quality care must only be carried out in specialised sarcoma centres (including paediatric cancer centres) which have both a core multidisciplinary team and an extended team of allied professionals, and which are subject to quality and audit procedures. Access to such units is far from universal in all European countries. It is essential that, to meet European aspirations for high-quality comprehensive cancer control, healthcare organisations implement the requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis and follow-up, to treatment, to improve survival and quality of life for patients. Conclusion: Taken together, the information presented in this paper provides a comprehensive description of the essential requirements for establishing a high-quality service for soft tissue sarcomas in adults and bone sarcomas. The ECCO expert group is aware that it is not possible to propose a 'one size fits all' system for all countries, but urges that access to multidisciplinary teams is guaranteed to all patients with sarcoma. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.

Cancer is a complex disease that is constantly evolving. It is now the most common cause of death in Europe after cardiovascular diseases. There are inequalities among European countries, potentially unsustainable healthcare systems impacting quality of cancer care and increasing number of patients with cancer with rare conditions. Clinical and translational research are the backbone in establishing scientific advances as novel treatments and advancing progress to the benefit of patients. Commercially sponsored clinical trials are responsible for developing new medicines that can treat various disease areas, including cancer. It is important to note, however, that these clinical trials only assess the viability of compounds that are chosen by a commercial entity that funds the entire process. By their design and focus, these trials need to fulfil commercial interests and market expectations, which do not always coincide with patients’ needs. As soon or even before novel treatments and compounds obtain formal market authorisation, academia will take these existing and new medicines to further conduct research in order to optimise their use, develop new combinations and with a strong focus on the patients and their needs. Established standard of care most commonly relies on clinical cancer research stemming from non-commercial entities, cooperative groups or academic clinical research. This article provides a consensus on the definition of academic research, illustrates its added value and suggests and calls to European Union institutions to support this type of research for the benefit of patients.

Independent applied clinical research addresses questions which are centered on optimization of treatments and patient management. It often finds itself confronted to policies and regulations implemented more specifically with pharmaceutical research and drug development in mind but which in practice apply throughout all clinical research programs. We report herein a specific case illustrating such challenges. We question how far legal constraints overshoot their initial objectives, leading to opposite effects for which they were set up. In an era where independent evaluation of cancer treatments is becoming so critical due to complexity, duplication and costs, comprehensive and pragmatic reform of our frameworks appears critical.

Background The academia-industry interface is important, and, despite challenges that inevitably occur, bears the potential for positive synergies to emerge. Perceived barriers to wider collaboration in academia-industry oncology research in Europe need to be addressed, current academic cooperative group and industry models for collaboration need to be discussed, and a common terminology to facilitate understanding of both sectors’ concerns needs to be established with an eye towards improving academia-industry partnerships on clinical trials for the benefit of patients with cancer. Methodology CAREFOR (Clinical Academic Cancer Research Forum), a multi-stakeholder platform formed to improve the direction for academic clinical trials in the field of oncology in Europe, formed the CAREFOR-Industry Working Group comprised of experienced professionals from European academic cooperative groups joined by industry representatives selected based on their activities in the area of medical oncology. They jointly discussed academic cooperative groups, clinical trials conducted between academic cooperative groups and industry, examples of successful collaborative models, common legal negotiation points in clinical trial contracts, data access, and principles of interaction. Results Four principles of interaction between the academia and industry are proposed: (1) clarify the roles and responsibilities of all partners involved in the study, (2) involve legal teams from an early stage; (3) acknowledge that data is an important output of the study, (4) agree on the intent of the trial prior to its start. Conclusions The CAREFOR-Industry Working Group describes current models, challenges, and effective strategies for academia-industry research in Europe with an eye towards improving academia-industry partnerships on clinical trials for patients with cancer. Current perceived challenges are explained, and future opportunities/recommendations for improvement are described for the areas of most significant impact. Challenges are addressed from both the academic and industry perspectives, and principles of interaction for the optimal alignment between academia and industry in selected areas are proposed.

Background:The Gynecologic Cancer InterGroup (GCIG) is a global consortium consisting of research groups from various countries to facilitate collaboration in clinical trials in gynecologic cancer; founded in 1993 and formalized in 1997. Global clinical trials often have multiple obstacles for operating them. To address such issues, the GCIG established a Harmonization Operations Committee in 2003. Achievements of this Harmonization committee are summarized.Methods:Minutes of GCIG meetings between 2004 and 2017 were reviewed. Participating member groups and Harmonization activities were summarized. Results:The average numbers of participant groups were 10.8 from 2004 to 2008, 17.0 from 2009 to 2013, and 19.1 from 2014 to 2017. The participant groups originated from Europe, North America, Latin America, Oceania and Asia. Total number of activities was 69. The major activities were aimed at overcoming international variations in managing clinical trials (eg. budgeting, insurance, data quality, communication amongst groups, etc.). The committee developed common templates, tools and policies, as well as minimum standards of data quality for GCIG trials, in order to facilitate intergroup collaboration. The committee also addressed issues in rare tumors, translational research and QoL/PRO instruments. Education, including mentoring, is ongoing.Conclusion:With growing recognition of the importance of operational harmonization in international trials, more groups have been participating in the Harmonization Committee. The committee has been challenging problems towards improving outcomes for patients. This review showed that operational harmonization is an essential component of successful international trials. The Harmonization Committee will continue to enhance high quality clinical trials for gynecologic cancer patients.

Introduction: Rare cancers together account for about 22% of new cancer diagnoses each year, which is more than any single common cancer. They constitute a serious public health problem with distinctive challenges. Compared with common cancers, less is known about their etiology and molecular pathology, and therapeutic options are mostly poorly evidence based with outcomes that are on average inferior to those of more common cancers. There is, therefore, a pressing need for well-organized clinical research to address these deficiencies. The International rare cancer initiative (IRCI) was formed in 2011 with the aim of stimulating and facilitating the development of international clinical trials for patients with rare cancers, and so helping to establish better, more evidence-based treatments. As of October 2013, 8 clinical trials are in design, in set up or recruiting, in seven rare cancer types, giving IRCI a good understanding of the current research conditions for rare cancer. Areas covered: This paper...

The demand for international collaboration in cancer clinical trials has grown stronger to maximize efficiency, avoid duplication of effort and to achieve effective implementation of research results into medical practice. Infrastructures that could facilitate intercontinental collaboration not only between Europe and United States but also between Europe and Asia are urgently needed. The European Organisation for Research and Treatment of Cancer, one of the major cancer clinical research infrastructure in Europe, initiated collaboration with the Japan Clinical Oncology Group, the largest cancer research cooperative group in Japan. Their first pilot trial on unresectable colorectal liver metastasis will commence on fourth quarter of 2016. With similar goals and strategies as well as with similar structures, the two research organizations have a great potential for efficient collaboration that could deliver faster and global therapeutic improvement to cancer patients. However, international collaboration requires careful and structured approach to harmonize activities to ensure success. This article focuses on specific intercontinental differences and the necessary requirements to ensure a successful partnership between European Organisation for Research and Treatment of Cancer and Japan Clinical Oncology Group. This could serve as a model to build more global international academic trials between the East and the West.

International investigator-driven clinical trials (IDCTs) satisfy international standards for quality, achieve maximum efficiency, avoid duplication of effort, and realize effective and widespread implementation of research results into medical practice. This article focuses on specific intercontinental issues involving the development and conduct of IDCTs and reviews what is necessary for a successful international partnership, specifically, intergroup trials involving the European Organisation for Research and Treatment of Cancer (EORTC) and the US-based National Cancer Institute intergroup system. Through examples, it is shown that the lead group of an international intergroup IDCT must have the expertise and capabilities to work effectively in the international setting, establish working procedures, consider the regulatory environment and QA/QC in the trial setting, and secure the principles of academic independence.