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EORTC at a glance Content FOREWORD............................................................................................................................................... 4 THE CRITICAL ROLE OF NON-COMMERCIAL RESEARCH ...................................... 7 The critical role of non-commercial research in fighting cancers and improving patients’ lives...................... 8 EORTC: A major player in international cancer clinical research................................................................. 10 EORTC: A pioneer in improving patients’ lives............................................................................................ 11 EORTC AT THE HEART.................................................................................................. 15 EORTC: Leading by example....................................................................................................................... 16 1. An international network of world-class expertise.................................................................................... 17 2. Cutting-edge expertise for fast-pace change............................................................................................. 18 3. Unwavering in its principles and values, and compliant with regulations and oversight........................... 19 4. Findings grounded in a large clinical research database of patient information........................................ 20 5. Setting quality standards in research and treatments................................................................................ 22 6. Solution-driven innovation...................................................................................................................... 24 7. Leaving no one behind............................................................................................................................ 26 SHAPING THE FUTURE OF THERAPY........................................................................ 31 Serving the oncology community................................................................................................................ 32 Shaping cancer therapy in partnership......................................................................................................... 34 EORTC funding: an investment with many returns....................................................................................... 40 Annual accounts.......................................................................................................................................... 42 EORTC PEOPLE.............................................................................................................. 45 EORTC Board.............................................................................................................................................. 46 EORTC Research Groups and Task Forces.................................................................................................... 47 Representatives of the top 15 recruiting institutions..................................................................................... 48 EORTC HQ Directors.................................................................................................................................. 49 EORTC HQ Coordination Committee.......................................................................................................... 50 2 | EORTC at a glance In over 50 years, 190,000 patients trusted EORTC by enrolling in its research. Each year, thousands more accept to enroll. This is why. EORTC at a glance |3 Foreword Shaping the Future of Cancer Therapy Over 50 years ago, visionary leaders in cancer medicine realized that advancement of patient management requires solid understanding of the disease and biology, rigorous testing of novel treatments, interdisciplinary collaboration, and exchange beyond state boundaries. Oncology has grown from small sub-disciplines of internal medicine, radiation therapy or surgery, respectively, to a large specialty of its own. The tremendous increase in knowledge, understanding, and treatment has led to organbased specialization. Today, inter-disciplinary collaboration and the integration of pharmacology, molecular biology, tumor immunology, and imaging are gaining increasing importance. We now understand that there may be common pathways leading to tumor proliferation. the specific molecular aberrations. Molecular tumor characterization is becoming a routine part of daily practice. Here, multi-stakeholder programs designed to improve the development of precision medicine and establish foundations for new health care delivery models will benefit patients with cancer. EORTC looks forward to pursuing its fruitful collaborations with all cancer clinical research stakeholders. Novel treatment strategies are oriented towards Roger Stupp EORTC President 4 | EORTC at a glance Working Together to Improve Cancer Treatment cancer clinical research stakeholders and to provide support to a network of experts. EORTC fulfills a central role as an international cancer clinical research infrastructure and is a unique leader in conducting non-commercial, academic, international cancer clinical studies. It has a mission to develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by prolonging survival and improving patient quality of life. In pursuit of this, we engage in numerous programs designed to bring together EORTC has long recognized that broad collaboration is necessary to improve treatments for patients with cancer, and these forms of partnership range from multidisciplinary collaborations among our investigators within clinical studies, to multi-stakeholder approaches to cancer drug development which include regulators, industry, academia, patients and payers. Full clinical, scientific, operational, quality assurance, and regulatory support for clinical studies is provided by the 180 EORTC Headquarters staff with strong expertise in biostatistics, clinical study design and methodology, endpoint definition and analysis, and new initiatives in imaging and long term survivorship. Our SPECTA (Screening Patients for Efficient Clinical Trial Access), cancer survivorship, as well as other emerging programs are blooming and complete our traditional agenda for clinical studies. These recent additions to our portfolio provide EORTC with new opportunities with further credit and visibility with partners such as regulators and payers. We continue to develop new forms of multidisciplinary partnerships which help optimize cancer clinical research in Europe and adapt to the changing landscape. Today, in a rapidly changing environment, EORTC is at the center of clinical research transformation. Denis Lacombe EORTC Director General EORTC at a glance |5 THE CRITICAL ROLE OF NON-COMMERCIAL RESEARCH The critical role of non-commercial research in fighting cancers and improving patients’ lives Despite recent progress, cancer is a still growing burden for humankind Cancer figures among the leading causes of morbidity and mortality in Europe and at the global level. In 2012, there were an estimated 3.45 million new cancer patients and 1.75 million cancerrelated deaths in Europe1 . Over the next two decades, the global number of new cases is expected to rise by about 70%, from 14 to 22 million. At the same time, more than 60% of the world’s total new annual cases occur in Africa, Asia and Central and South America. These regions account for 70% of the world’s cancer deaths2. This strong growth in the number of cancer affected patients and the shift towards poorer countries will, as a consequence, increase inequalities and the economic burden of healthcare, which developed countries are already facing. The pivotal role of clinical research While cancer can be reduced and controlled by implementing strategies for prevention, early detection and management of patients, investigator-driven clinical research plays a pivotal role in shaping the future of cancer therapy by: • • • • • Promoting innovative research and rapid access to new agents Translating laboratory discoveries into practice Defining state-of-the-art treatment Identifying ineffective and/or redundant treatments Guaranteeing best medical practice 8 | EORTC at a glance In addition, EORTC’s own approach to clinical research ensures: • Independent objective evaluation • Multidisciplinary strategies • Studies on rare cancers The role of non-commercial research in Europe In Europe between 2005 and 20133 , all disciplines included, commercial sponsors conducted 61% of all clinical studies, while non-commercial sponsors (among which EORTC) conducted 39% of all clinical studies. It is noteworthy that non-commercial studies are almost exclusively national in scope, accounting for roughly half of all studies carried out at the national level. In these respects, EORTC stands out and occupies a unique space among clinical trial sponsors by harnessing an international network of world-class experts in interdisciplinary collaboration and exchange beyond state boundaries. As we move into an era of personalized medicine, this approach is proving to be even more important. Ferlay et al., EJC 2013;49:1374-1403. World Health Organization, World Cancer Report 2014, Fact sheet N°297 Updated February 2015. 3 European Medicines Association, Drug Information Association, 23-24 September 2014. 1 2 EORTC at a glance |9 EORTC: A major player in international cancer clinical research EORTC is a private non-profit and independent cancer research organization founded in 1962, whose mission is to coordinate and conduct international translational and clinical research to improve the standard of cancer treatment for patients, and ultimately increase survival and quality of life. Today EORTC conducts a large share of European non-commercial studies (see chart below) and has extensive experience in working with many stakeholders across national borders, among which academic medical centers, research organizations, pharmaceutical companies, regulators and other healthcare interested parties. 42% of European non-commercial studies were conducted by EORTC between 2005 and 20134 EORTC by the numbers • 185 employees • > 190,000 patients in the databases • > 23,000 patients in follow-up • > 200 active studies • 46 studies open to patient entry at any time • 156 ongoing projects • 21 Groups and Task Forces • > 4,600 collaborators in 37 countries, in more than 600 institutions • > 1,900 publications with EORTC in the titles and/or with EORTC affiliation Commercial Non-commercial 4 European Medicines Association, Drug Information Association, 23-24 September 2014. 10 | EORTC at a glance EORTC: A pioneer in improving patients’ lives Patients’ survival and quality of life lies at the heart of EORTC’s approach to research. Over 50 years since its creation in 1962, EORTC conducted over 1,900 studies, many of which have resulted in life-changing treatments and the establishment of new standards of care or, conversely, shown the inefficacy or redundancy of others. Patient quality of life Radiotherapy Translational research disciplines Patientdriven precision medicine Designing strategies that improve patient survival and quality of life Medical oncology Improving patient safety Surgery Survivorship & outcome research To achieve this, EORTC applies an interdisciplinary methodology, mobilizes a broad network of clinicians and medical scientists and involves thousands of patients with the clear aim of improving the standard of cancer treatment through the testing of more effective strategies based on therapies that are already in use. All of these together, researched and tested alongside each other, increase knowledge, improve treatments and shape the future of cancer therapy. EORTC at a glance | 11 EORTC: a pioneer in Quality of Life research for decades Patient Reported Outcomes Guidelines stress how Quality of Life is a critical factor to evaluate in patients, especially when innovative treatments are discovered. Here the EORTC plays a leading role in its capacity as an international leader in methodological research in measuring Health- Related Quality of Life in oncology. Quality of Life results from EORTC Clinical Studies have had a positive impact on clinical practice in the treatment of numerous diseases such as brain, breast, melanoma, lung and ovarian cancer. The EORTC Quality of Life Core Questionnaire, the QLQ-C30, is one of the most widely used cancer specific Health Related Quality of Life questionnaires in the world. It has been translated and linguistically validated into more than 90 languages and extended with over 40 validated modules for specific cancers. EORTC validated modules are available for: • • • • • • • • • Bone Metastases Hepatocellular Carcinoma Brain Breast Lung Cervical Multiple Myeloma Colorectal Neuroendocrine Carcinoid 12 | EORTC at a glance • • • • • • • • • Colorectal Liver Metastases Esophageal Elderly Cancer Patients Esophago-Gastric Endometrial Ovarian Gastric Prostate Head and Neck EORTC’s mission statement EORTC aims to develop, conduct, coordinate, and stimulate international translational and clinical research to improve the standard of cancer treatment for patients, and ultimately increase survival and quality of life. EORTC at a glance | 13 EORTC AT THE HEART EORTC: Leading by example EORTC’s experience over decades, its interdisciplinary approach, its international network of world-class expertise and its independence from commercial industries have propelled it to the forefront of cancer clinical research where it enjoys an internationally acclaimed reputation that revolves around a number of core features. EORTC’s equity and core features 7. No one left behind 6. Solution-driven innovation 5. Quality assurance International • Interdisciplinary • Multi-tumor • Regulatory compliant • Independent 4. Data-driven analysis 16 | EORTC at a glance 1. Expert network 2. Cutting edge expertise 3. Unwavering independence and accountability 1. An international network of world-class expertise Extensive and comprehensive studies in the wide field of clinical research are usually beyond the means of a single hospital or university. It can best be done when medical scientists and clinicians join forces around the patients’ needs in interdisciplinary and international efforts. EORTC’s network is the infrastructure of its research model An unparalleled international network of patients and professionals • 190,000 patients • Patients associations • 37 countries Expertise at work in collaboration • 4,600 scientists and clinicians • 640 hospitals • 100 collaborative working groups 21 research groups • Interdisciplinary & multi-tumor • Over 1,900 studies completed and 200 under way • 185 staff EORTC at a glance | 17 2. Cutting-edge expertise for fast-pace change EORTC’s research addresses key strategic clinical questions and influences medical practice. It covers a wide range of cancer disciplines and responds to unmet needs. Its interdisciplinary approach includes surgery, radiotherapy, medical oncology, pathology, immunology, infectious diseases, genetics, psychology, health economics… All of these are complemented by other services in early project optimization, quality of life, meta-analysis, quality assurance, monitoring, regulatory affairs and pharmacovigilance. Unique infrastructure A interdisciplinary network of investigators and translational scientists across Europe Oustanding track record A clinical research infrastructure meticulously engineered through peer reviewed policies and standard operating procedures Scientific quality ... guaranteed by world class independent peer review committees Acclaimed leadership in clinical research across disciplines Integrated research Regulatory and operational skills Capacity building 18 | EORTC at a glance Quality of life Quality assurance programs Rare cancers in information technology Survivorship and Technical expertise outcome research in imaging and radiotherapy Molecular screening and biomarker programs for Specific population: precision medicine such as elderly data management regulatory and legal considerations Education in cancer clinical research methodology and related topics: courses and conferences; fellowship program 3. Unwavering in its principles and values, and compliant with regulations and oversight To maintain its focus on improving patients’ survival and lives, and ensuring robust study results, EORTC holds firmly to a set of academic, scientific and ethical principles of collaboration and transparency, while complying with strict oversight procedures. Principles of independence Principles on data-sharing • Peer review process / approval (Protocol Review Committee) • Database control by academia (Independent Data Monitoring Committee) • Analysis of primary endpoints • Publication of primary analysis • Charters for the use of human biological material • Compliance with OECD Principles and Guidelines for Access to Research Data from Public Funding • Release of data once the primary study results are mature and validated • Protection of individual patients’ rights to privacy Control mechanisms Action mechanisms • Quality Assurance Committee (L. Licitra, Milano, IT) • Scientific Audit Committee1 (I. Tannock, Toronto (CA) (until 31 March 2016) E. Eisenhauer, Kingston (CA) (as of 01 April 2016)) • Institutional Review Board Committee2 (A. Negrouk) • Membership Committee (M. Grønvold, Copenhagen (DK)) • Protocol Review Committee3 (F. Shepherd, Toronto (CA)) • New Drug Advisory Committee4 (JP. Bizzari, New York (US)) • Translational Research Advisory Committee5 (S. Tejpar, Leuven (BE)) • Independent data Monitoring Committee6 (M. Mason, Cardiff (UK)) Ensures quality of the science and medicine Safeguards rights and welfare of patients in clinical studies 3 Ensures academic independence 4 Expedites the introduction of new drugs 5 Ensures relevance and quality of translational research studies 6 Reviews interim analyses of EORTC and intergroup studies for which EORTC is the coordinating group 1 2 EORTC at a glance | 19 4. Findings grounded in a large clinical research database of patient information Since the late 70’s, EORTC’s IT experts have continuously been developing tailored software solutions that allow for the management of increasingly diverse and complex clinical studies data. Integrating all sources of data Radiotherapy images and data Diagnostic and moleculat imaging data Biological data Clinical data CLINICAL DATA: VISTA TRIALS (Visual Information System for Trials Analysis) is the clinical data management system developed in-house and used to run all clinical data activities at EORTC Headquarters. It hosts a suite of applications ranging from: • Remote Data Capture (RDC) • Patient Review • Form Tracker • Database definition • Statistical analysis system (SAS) export module • Online Randomized Trials Access (ORTA) for web-based patient registration and randomization 20 | EORTC at a glance RADIOTHERAPY IMAGES AND DATA to ensure Radiotherapy Quality Assurance (RTQA). DIAGNOSTIC AND MOLECULAR IMAGING DATA • Imaging platform with easy upload portal allows secure and protected transmission of patients’ images: • Reviewing functionalities powered by VISIO+, a medical image analysis tool • Collected images stored centrally and linked to patients’ clinical data • Central review via any internet workstation (does not require software installation) BIOLOGICAL DATA • Sample tool for biological data. • Satellite applications, e.g. regulatory database offering full compliance to regulations. • PRISMA, EORTC’s clinical trial management system, provides a global overview of all projects and detailed information about specific protocols (centers, investigators, study milestones, etc.). The clinical studies databases are designed by implementing CDISC (Clinical Data Interchange Standards Consortium) principles. VISTA Trials was developed on the CDISC operational data model backbone. A web based release supports CDISC standards from form design through data exports. All software developed at EORTC Headquarters follows a standard system development life cycle and complies with United States Food and Drug Administration 21-CFR part 11 (electronic records electronic signature) and EudraLex Volume 4 Annex 11: Computerized Systems. EORTC at a glance | 21 5. Setting quality standards in research and treatments Quality assurance cannot be compromised and is essential for conducting robust and effective cancer clinical studies. Ongoing quality assessment of clinical studies is performed both at EORTC Headquarters and at investigational sites. EORTC also promotes and encourages quality awareness throughout the organization and provides expertise in developing and maintaining clinical research of high quality. EORTC’s quality assurance aims at: • Practical quality control to ensure a level of clinical practice that strengthens the scientific value of the studies • Standardizing therapeutic practices in participating centers • Raising the level of medical practice in oncology Radiotherapy Medical oncology Surgery Quality assurance applied to ... Medical imaging 22 | EORTC at a glance Translational research biobanking and pathology • EORTC’s integrated Radiotherapy Quality Assurance (RTQA) helps to develop truly effective combined treatment modalities. It harmonizes treatment techniques between centers, standardizes credentialing of modern techniques, enhances compliance with the study protocol and increases public and regulatory acceptance of drug effect. Working within the Global Clinical Trials Quality Assurance of Radiation Therapy Harmonization Group, EORTC seeks to harmonize and improve the quality assurance of radiation therapy implemented worldwide for the treatment of cancer. • The SURCARE partnership between EORTC, the European Society of Surgical Oncology, and the Japanese Clinical Oncology Group seeks to improve the quality of surgery in cancer clinical studies by developing methods to credential surgical expertise, standardizing surgical techniques, and centralizing the monitoring of surgical outcomes. The CLIMB project, for initially unresectable liver metastasis from colorectal cancer, evaluates complications after surgery, and develops thresholds for quality. The DREAM project seeks to determine the accuracy of DW-MRI (Diffusion-weighted Magnetic Resonance Imaging Assessment for Liver Metastasis) in evaluating sites where liver metastases disappear after conversion chemotherapy, with the goal of using it as an imaging biomarker to guide surgeons in planning treatment of complex liver metastases. As of January 2016, 26 international clinical institutions will participate in SURCARE, 400 patients will enroll in the DREAM trial, 100 post-operative patients will participate in the CLIMB trial and 12 European countries and Japan form the SURCARE network. • Access to human biological materials, in sufficient quality and quantity and linked to high quality clinical data is essential to accelerate clinical and translational cancer research. EORTC studies comply with all applicable ethical, legal and quality assurance requirements regarding the collection of human biological materials. These are then stored in a validated storage facility and comply with EORTC’s Human Biological Material Collection, Storage and Use policy. • EORTC’s Imaging Platform ensures proper implementation of the different medical imaging modalities, protocol and imaging guideline compliance, quality control of scans, analysis of deviations, and process improvements for clinical studies. 4,000 images have been centralized at EORTC’s imaging platform since 2011. 10 studies are under way with imaging central review to confirm quality and diagnosis, as well as 3 imaging biomarker driven studies. Real-time scan quality control within 3 working days for 5 ongoing studies. EORTC at a glance | 23 6. Solution-driven innovation EORTC is on a constant look-out for new or better solutions for improving the survival and lives of patients. It pushes boundaries, step-changes treatments and applies new ideas to old problems. Today, EORTC is breaking new ground in two areas. SPECTA • Screening patients for efficient clinical trial access • Breaking the silo approach to precision medicine Exploring drugs and combinations across a range of tumors How the presence of a molecular marker can predict response to a targeted therapy SPECTA: First pan-European molecular screening platform acting across tumor types Why SPECTA? The understanding of tumor biology has improved, continues to expand at a rapid pace, and is opening new opportunities for cancer clinical studies. The identification of molecular alterations in the cancer, and the possibility to specifically and selectively target them, has dramatically improved treatment efficacy in cancer patients. SPECTA has embraced this change. Positioned in Europe as a unique, international, cross tumor, and multidisciplinary clinical research infrastructure, EORTC stands out with supportive assets that enable it to integrate clinical, biological, and imaging data with high quality, longitudinally annotated human biological material collection in a regulatory compliant environment, all guiding principles and pillars at the basis of the SPECTA Program. 24 | EORTC at a glance What is SPECTA? SPECTA is a pan-European network built by EORTC with key institutions collaborating to provide efficient access for patients to molecularly driven clinical studies. • To date, the SPECTA platforms for colorectal cancer and thoracic tumors are fully operational, thus proving that a logistically complex infrastructure to run innovative studies in a multinational setting is feasible. • Additional platforms for patients with brain tumors, melanoma, prostate, and rare tumors are planned to open soon. EORTC has a collaborative network for reliable and effective development of innovative drugs and companion diagnostics. SPECTA: a place to meet for all stakeholders involved in precision medicine • Collaborative longitudinal clinically annotated biobanks and molecular screening platforms, shared risk and benefit model between academia, industry and healthcare providers • Rapid access to patients’ clinico-pathological data and molecular profiles to identify molecular sub-groups of patients based on biomarker identification and validation • Efficient access to innovative, biomarker driven, statistically sound basket clinical studies within the individual platforms and cross-platform umbrella studies targeting specific molecular alterations for small cohorts of patients Skillfully Exploring Drugs and Combinations across a Range of Tumors EORTC has the flexibility and skills to design, develop and conduct clinical studies based on the idea that the presence of a molecular marker can predict response to a targeted therapy, and the study design is independent of tumor histology. With its proven infrastructure, EORTC can support multiple tumor types and molecular markers. EORTC trial 90101 CREATE: an EORTC basket trial CREATE is a phase 2 trial assessing the efficacy of crizotinib in a variety of tumors with specific alterations leading to ALK and/or MET activation. The trial also includes patients with the same tumor types without specific ALK or MET alterations in a population comprising 582 patients with the following diagnoses: • Anaplastic large cell lymphoma (ALK alterations) • Inflammatory myofibroblastic tumor (ALK alterations) • Papillary renal cell carcinoma type 1 (MET alterations) • Alveolar soft part sarcoma (MET alterations) • Clear cell sarcoma (MET alterations) • Alveolar rhabdomyosarcoma (MET and ALK alterations) EORTC at a glance | 25 7. Leaving no one behind Under the pressures of economic purposes or schools of thought, research can sometimes lose sight of the patient’s best interests or even of groups of patients altogether. It can also focus on cancers that affect the largest number of people and forget about rare cancer types. Because it was created to improve the treatment of all cancer affected patients, EORTC is committed to leaving no one behind. Rare tumor types Cancer survivorship EORTC is committed to ... The elderly 26 | EORTC at a glance Children Rare Tumor Types EORTC makes a significant and valuable contribution to rare cancer clinical research: • By conducting over 50 international clinical studies in a range of rare disease entities such as: lymphomas, melanoma, leukemia, sarcoma, brain, mesothelioma, penal, vulval, salivary gland, male breast and anal. • By participating in the International Rare Cancers Initiative (IRCI), a joint initiative between EORTC, United States NCI, NIHR Cancer Research Network, and Cancer Research UK • By bringing together select researchers and organizations for the purpose of developing new therapies for rare diseases as well as the means to diagnose them. This is witnessed through its active and leading participation in International Rare Diseases Research Consortium (IRDiRC), where EORTC Director General Dr. Denis Lacombe serves on the IRDiRC Executive Committee, and through its participation in several European Commission funded projects in rare cancers such as EUROSARC, EEC EURO EWING - International Clinical Trials to Improve Survival from Ewing Sarcoma, and the International Study for Treatment of Childhood Relapsed acute lymphoblastic leukemia (IntReALL), and is member of Rare Cancers Europe (RCE). • By tackling rare cancer clinical research through its SPECTArare platform. EORTC at a glance | 27 Cancer Survivorship Survival rates of cancer patients have significantly increased over the past decades. But even as cancer is controlled in many patients, new problems are becoming increasingly associated with cancer survivorship. Difficulties such as societal discrimination due to slower performance, chronic fatigue or partial inability, acceptance for work, education, insurance or credit history are all things that impact the life of a cancer survivor. Having successfully completed survivorship activities in breast cancer, lymphoma, testis cancer and children’s leukemia, EORTC is applying its structured approach to a new set of activities. In particular, it is actively involved in a European network of organizations and patients cohorts that addresses the issue of cancer survivorship by quantifying the magnitude of the problem, assessing its economic burden and formulating evidence-based EU recommendations for rehabilitation of cancer survivors. This joint effort has proven that it eliminates redundancy and synergizes expertise and methodology, including data from clinical studies, (population-based) cancer registries, surveys and social media. EORTC’s Cancer Survivorship Summits (2014 and 2016) address issues and topics such as: • Physical/Medical - pain, fatigue, memory problems, lymphedema, infertility, sexual impairment, amputations, secondary malignancies, cardiovascular, pulmonary, renal disease, neuro/muscular impairments • Psychological - depression, anxiety, uncertainty, isolation, altered body image • Socio - economic - changes in interpersonal relationships, concerns regarding health or life insurance, job lock/loss, return to school, financial burden 28 | EORTC at a glance Cancer in the Elderly Current challenges in geriatric oncology revolve around the selection of patients for specific treatments and the delicate balance in prolonging survival while maintaining independence, functionality and quality of life. Elderly patients have often been shown to receive comparable benefit from treatments as their younger counterparts and should not be denied access to treatments based on chronological age alone. Unfortunately, elderly patients are underrepresented in cancer clinical studies, and it is hard to form evidence-based clinical recommendations in everyday clinical practice. Here, EORTC is also shaping the future for the treatment of elderly patients with cancer. • Elderly patients with HER-2 positive metastatic breast cancer: with very well tolerated new targeted therapies, EORTC hopes to control tumor growth sufficiently long so that toxic chemotherapy would not be needed. Many older patients would more likely die from ageing than cancer. • EORTC-Alliance-SIOG underlines the need for appropriate endpoints and designs for clinical studies in elderly patients: randomized phase II or even single arm phase II studies in specific subsets of elderly patients could provide insight in the range of efficacy and toxicity in older populations. • Describing potential biomarkers to indicate functional biological age of elderly patients with cancer: studies have shown that slightly more than half of all newly diagnosed cancer cases and more than two thirds of cancer-related deaths occur in patients 65 years or older. Doctors will increasingly need to make treatment decisions for older patients, and to make effective decisions, we will need better biological markers of aging. • Cancer diagnostic/treatment approaches in nursing homes with the support of Armonea: for older individuals, EORTC expects to find a conservative, palliative treatment in the majority of cases. This prospective observational study seeks to open the discussion on this delicate issue starting with a solid and extensive description of the present situation. EORTC at a glance | 29 SHAPING THE FUTURE OF THERAPY Serving the oncology community As a not-for-profit organization focused on improving the patient’s survival and life, EORTC looks at the oncology community at large not only to draw on its expertise but also to build and strengthen it. On an on-going basis, EORTC organizes conferences and events, offers multiple educational modules, and trains dozens of fellows annually in clinical research. EORTC also believes in sharing mature and validated data. Serving the oncology community Training fellows Sharing data Events & education EORTC events and education 2016 • 2nd EORTC Cancer Survivorship Summit • Clinical Trial Statistics for nonStatisticians • Navigating Safely through the Regulatory Triangle: Clinical Trials – In vitro Diagnostics – Data Protection • Innovation and Biomarkers in Cancer Drug Development (IBCD) • A One-Day Journey through EORTC Activities 32 | EORTC at a glance • 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics More information about EORTC conferences and education available at www.eortc.org/events Fellowship EORTC Fellowship program opens the door to a career in cancer clinical and translational research. Established in 1991 to promote European cancer clinical research, EORTC Fellowship Program encourages physicians, statisticians and scientists from all over the world to train for up to three years at EORTC Headquarters in Brussels. This program is specifically linked to EORTC Groups, EORTC research program, or specific research projects undertaken by EORTC Headquarters. The program provides training in the methodology of clinical research for physicians and other professionals interested in cancer clinical research, and it is possible to complete a research project and/or PhD thesis based on data available in EORTC databases. All research work is performed internationally, and this approach promotes rapid dissemination of clinical trial results. Financial support for EORTC Fellowship Program is obtained from several sources including the Vlaamse Liga tegen Kanker, the Dutch Konigin Wilhehmina Fonds Kankerbestrijding, the Schroeder Foundation, the Melvin Seiden Foundation, Vivaqua, Sally Snowman Survivorship Initiative and the Pfizer Foundation (within the framework of the PROBE Project). It is coordinated by EORTC Cancer Research Fund. In addition to support from EORTC, fellowships for medical doctors are also provided on ongoing basis by the Fonds Cancer / FOCA, Belgium. From 1991 to 2006: >150 fellows from 36 nationalities; 48 PhD theses. Data sharing Access to international data helps produce a better understanding of public health issues and worldwide disease prevention and control, and EORTC makes data from its clinical studies available to other academic researchers. As of 2016 EORTC has provided data to 199 ongoing external projects (96 closed, 103 ongoing). Considering that on-going research contributing to the completion of datasets must not be compromised by premature or opportunistic sharing and analysis of data, EORTC only releases data once the primary study results have been published. Any release of data will take into consideration individual patients’ rights to privacy. Investigators who would like to use data from one or more EORTC studies must make a formal request which is reviewed by EORTC Coordinator for External Research Project. The scientific merit and feasibility of each request will be evaluated. EORTC’s policy on data sharing builds on the central principles of the Organization for Economic Co-operation and Development (OECD) in its report OECD Principles and Guidelines for Access to Research Data from Public Funding. EORTC at a glance | 33 Shaping cancer therapy in partnership As described previously, EORTC’s research model is built around a network of world-class experts in hospitals and universities across Europe, and a robust platform of researchers and statisticians in its headquarter offices in Brussels. But beyond this core infrastructure, EORTC continuously engages strategically with other stakeholders whose missions, roles and responsibilities have a direct bearing on cancer clinical research. EORTC’s partnership framework Clinical researchers Patients Healthcare industry Governments EORTC Regulatory authorities Payers European Commission 34 | EORTC at a glance Patients: listening to and training the beneficiaries Working closely with patient organizations brings a critical eye to EORTC activities. EORTC has close relationships with most patient organizations and cancer leagues across Europe. They provide EORTC with precious information and feedback on designing information sheets and informed consent forms, and help in the dissemination of information about progress in EORTC’s studies. In turn, EORTC hosts a two-day course designed for patient group leaders with a minimum of three years’ experience in cancer patient advocacy/patient support/patient information provision. The objective of this course is to provide high level cancer patient advocates with a stimulating and challenging training experience leading to a much greater understanding of the entire clinical studies process. During the course, they also learn about cancer biology, personalized cancer treatment and care, the organization of clinical research and, importantly, how patient groups can become closer partners in the design and implementation of clinical studies. Academic Networks and learned societies: win-win cooperation The complexity of cancer and the current cancer research landscape increasingly require greater structured cooperation and partnerships with other learned societies. Due to the emergence of new academic groups as well as the fragmentation of tumors based on molecular characteristics, cooperation with other investigator networks is strategically important to ensure rapid patient recruitment and more effective clinical/translational research. In a win-win model, learned societies benefit from EORTC’s clinical research expertise while EORTC can implement complex research programs with the quality assurance required. EORTC has collaborative projects with national/population based registries. Newly developed projects not only address the validation of clinical trial outcomes in real life but also improve the processes for data collection with registries and long term follow-up within joint projects. This provides a unique setting for addressing issues of big data and data merging challenges which will help increase our knowledge. The Healthcare Industry: balancing interests and principles EORTC successfully conducted studies in partnership with the healthcare industry that eventually changed practice. the Under the condition that they serve the best interest of all parties and lead to therapeutic improvements for patients, these studies aim either prospectively or retrospectively at drug registration. EORTC at a glance | 35 However, new forms of partnerships between industry and academia will need to be envisioned as modern clinical studies require long-term maintenance of technical and cross-validated infrastructure which is neither in the scope nor in the capacity of industry. New agents can be best and more rapidly developed if studied in high quality academic environments. Molecular sub-division of tumor entities imposes the organization of efficient and international networks for large screening programs for complex studies which cannot be administered outside an optimally controlled and well-managed infrastructure with the aim of avoiding duplication of screening efforts by industry. Complementary commercial and non-commercial agendas need to evolve to ensure the principles of independence that are so critical for the scientific and patient communities. Both parties need to address data access policies for shared knowledge and stimulate scientific thinking while new approaches to Intellectual Property challenges need to be developed. While the integration of agendas alongside efficient developmental activities and avoiding duplication of effort should be a cost efficient approach, financial support will remain a major challenge for complex, cutting edge clinical and translational research. EORTC has made substantial progress in facilitating interactions with industry for drug development. Today, the operations to conduct clinical studies and data exchange policies take into account the interests and needs of the partners. It is critical for both industry and academia, when partnering on studies which go beyond the single drug development approach, that the principles of non-commercial independence are respected. The forms and the methods of cooperation with industry are constantly evolving but are based on a good balance between academic independence and sets of procedures ensuring full visibility for industry. EORTC clinical data based are CFR part 11 and CDISC compliant to facilitate partnerships with industry. Regulatory Authorities: influencing policy Constructive dialogue with regulatory bodies is crucial to ensure that, as they are designed, legal frameworks take into account non-commercial research. In this spirit, EORTC has established and enjoys open communication with the European Commission and national regulatory agencies. In particular, EORTC advocates for the need of non-commercial research and of precision medicine, and about the issues surrounding rare cancers. 36 | EORTC at a glance In recent months, EORTC engaged in: • The Finalization of the European Clinical Trial Regulation: In dialogue with the European Medicines Agency, EORTC takes part in the stakeholder working group regarding the implementation of the European Clinical Trial Regulation. • Discussions on the EU Data Protection Regulation: Data privacy is currently one of the most debated topics within the European Union, and now is the time to take a close look at the topic from the angle of transparency in clinical studies and, more broadly, in health research. EORTC actively urges all stakeholders, EU commission, EU parliament and Member States to look at the data protection regulation from the perspective of individual patient data sharing under the scope of the clinical trial regulation. • Discussions on the in vitro Diagnostic Medical Devices Regulation: Treatments in today’s cancer clinical studies are more targeted. They incorporate technologies that exploit an ever increasing understanding of cancer biology, and new regulations for these technologies are on the horizon. Here, EORTC is very involved in making sure that discussions are held to explore the interface between the Clinical Trial Regulation, expected to be applicable in 2016, and the In Vitro Diagnostic Medical Devices and Data Protection Regulations now being discussed by the EU Parliament and Council, and how these three regulations will influence cancer research practice. • The European Medicine Agency: EORTC sits on the Scientific Advisory Group (SAG) and contributes to methodological projects in partnership with regulators. The European Union: Funded Projects EORTC does not receive core structural support from the European Commission, but it applies to calls for projects. Horizon 2020: The H2020 MOTRICOLOR project “MOleculary guided Trials with specific treatment strategies in patients with advanced newly molecularly defined subtypes of COLORectal cancer” benefits from EORTC’s proven infrastructure for performing biomarker-driven phase II clinical studies in this disease. EIT – Health “InnoLife”: The project Rare Cancer KIC “Establishing a knowledge innovation community for the societal and market challenge of rare cancer” involves SPECTArare as the backbone of an international platform involving academia and industry for validating new technologies usable for research, diagnostic and care of cancer patients. Innovative Medicines Initiative: By participating in projects such as those put forth by the Innovative Medicines Initiative, EORTC has become one of Europe’s leading players in transforming experimental discoveries into new treatments with a significant clinical impact. EORTC at a glance | 37 • PHARMATRAIN - with its top class training materials for cancer clinical trial professionals, EORTC makes a valuable contribution to PharmaTrain which provides accreditation and professional certification to ensure the competence of medicines development scientists and clinical investigators. • QUIC-CONCEPT – aims to provide drug developers with imaging biomarkers that can show earlier and more accurately how patients’ tumors respond to drugs in cancer clinical studies. • EUPATI - aims to provide scientifically reliable, objective, comprehensive information to patients on pharmaceutical research and development and increase the capacity of wellinformed patients to be effective advocates and advisors, for example in clinical studies, with regulatory authorities and in ethics committees. • GetReal - aims to inform pharmaceutical R&D and healthcare decision makers how real-world data and analytical techniques can be used to improve the relevance of knowledge generated during development, and how this can inform clinical decision making and improve the efficiency of the R&D process. 38 | EORTC at a glance Seventh Framework Program • ECRIN has provided EORTC with the opportunity to upgrade VISTA TRIALS and deploy this proprietary clinical database management software across Europe. • Euro-BioImaging - This large scale pan European research infrastructure project has enabled EORTC to develop the concept for an international imaging support node for international clinical studies. • EUROSARC - Clinical studies for rare cancers are a designated strategic need of EORTC. EUROSARC aims to validate novel local and systemic treatment strategies in localized phase sarcomas, and innovative targeted therapies in advanced phase sarcomas based on the scientific understanding of molecular alterations driving the tumors. • HERMIONE-2MAN - A first in man clinical trial with a first in class bio-therapeutic agent, the anti-Netrin-1 mAb, which targets a novel signaling pathway and offers potential treatment for a variety of cancers. • EEC - EURO EWING Consortium – Aims to improve treatment outcomes for patients with Ewing sarcoma, a rare cancer. Here two clinical studies will test different chemotherapy treatments for this rare disease o EORTC trial 1402 “International Randomized Controlled Trial for the Treatment of Newly Diagnosed Ewing’s Sarcoma Family of Tumors – Euro Ewing 2012” o EORTC trial 1403 "International Randomised Controlled Trial of Chemotherapy for the treatment of Recurrent and Primary Refractory Ewing Sarcoma - rEECur” EORTC at a glance | 39 EORTC funding: an investment with many returns EORTC is very grateful to all of its donors and partners who help it achieve its mission. It wishes to express its deep appreciation to: EORTC Cancer Research Fund Armonea The Belgian Lottery Cancer Leagues Prince Alwaleed Foundation Sir Ronald Grierson The Schroder Family Foundation Walgreens Boots Alliance The Gillings Foundation NCI USA Nicolas and Margo Snowman Ms de Spoelbergh The European Commission Fonds Baillet Latour FOCA (Fonds Cancer) *** To stay true to its mission of improving treatment for patients and shaping the future of cancer therapy, EORTC needs to retain full independence over its research. Consequently, it is a not-forprofit organization under Belgian Law and is not subsidized. All of its revenue is composed of grants from institutional, corporate and private donors, and of fees it charges for studies conducted in partnership and for services it renders to the oncology community (e.g. events). In most cases, grants are directed to specific projects, but they also can be invested in EORTC with the purpose of financing research on rare cancers and therapies with low commercial value but high impact for patients. Grants of that nature also “move the needle” in the fight against cancers. *** Supporting EORTC in its mission is the right choice: • Making a grant directly to EORTC is in essence improving the lives of thousands of patients and shaping therapy for many more in the future, as EORTC’s track-record shows; • Investing in EORTC is joining forces with an authoritative and leading partner, whose research model is unique in its interdisciplinary and multi-tumor approach; • Selecting EORTC is choosing to tackle the issue and the plight of cancer beyond medical siloes and national boundaries. 40 | EORTC at a glance Supporting EORTC in its mission is an investment with many returns: • Social impact for all donors, through the progress made each year in the treatment of cancer and the improvement of patients’ lives; • Corporate social responsibility (CSR) through the tackling of a major global health issue; • Achieving social objectives for trusts and foundations who seek to invest in effective strategic partnerships; • Equity, for those who seek to strengthen brand image among stakeholders (consumers, shareholders, employees…) *** The EORTC Cancer Research Fund Created in 1976, the ECRF collects grants necessary to conduct EORTC’s clinical research program. This is achieved thanks to the valued contributions of public and private donors. If you wish to support EORTC research: Friends of EORTC, for donations from the United Kingdom • IBAN: GB 30 COUT 1800 0201 8843 95 • SWIFT: COUT GB 22 EORTC Cancer Research Fund, for donations from Belgium • IBAN: BE79 0682 4292 7433 • BIC: GKCCBEBB Fondation Française pour la recherche et le traitement du cancer, for donations from France • IBAN: FR 76 3000 4009 3200 0100 3025 923 • BIC: BNPAFRPPMDT All donations are subject to /eligible for tax deductibility, subject to /in compliance with national laws of the countries of origin. EORTC at a glance | 41 Annual accounts6 Balance sheet 2014 (in Euros) 1. Assets 1.1. Fixed assets 1.1.1. Intangible fixed assets 1.1.2. Tangible fixed assets 1.1.3. Financial fixed assets 1.2. Current assets 1.2.1. Amounts receivable within one year 1.2.2. Current investments 1.2.3. Cash at bank and in hand 1.2.4. Deferred charges and accrued income 2. Liabilities 2.1. Equity 2.1.1. Association or foundation funds 2.1.2. Allocated funds 2.1.3. Accumulated result (+/-) 2.2. Liabilities 2.2.1. Amounts payable within one year 2.2.1.1. Trade debt 2.2.1.2. Advances received on contracts in progress 2.2.1.3. Taxes, remuneration and social security 2.2.2. Other amounts payable 2.2.3. Accrued charges and deferred income 42 | EORTC at a glance 93,015,903 292,042 61,237 230,383 422 92,723,861 15,232,838 57,645,684 18,833,015 1,012,324 93,015,903 56,589,246 19,085,702 17,301,808 20,201,736 36,426,657 25,133,792 2,642,665 20,433,713 1,582,398 475,016 11,292,865 Income statement 2014 (in Euros) 1. Operating income 1.1. Turnover 1.2. Other operating income 2. Operating charges 2.1. Services and other goods 2.2. Remuneration, social security costs and pensions 2.3. Depreciation of and amounts written down on formation expenses, on intangible and tangible fixed assets 2.4. Other operating charges 3. Operating result (+/-) 4. Financial income 5. Financial charges 6. Result on ordinary activities (+/-) 28,580,370 19,478,012 9,102,358 25,843,567 13,081,404 10,011,902 253,565 2,496,696 2,736,803 660,085 117,727 3,279,161 Source: Central Balance Sheet Office at National Bank of Belgium (https://www.nbb.be). EORTC’s accounts for fiscal year 2015 will be published after their approval by EORTC’s General Assembly of June 2016. 6 EORTC at a glance | 43 EORTC PEOPLE EORTC Board Full members (voting) Roger Stupp President Jean-Yves Blay Past President Vincent Grégoire Vice-President Patrick Schöffski Secretary General Martin van den Bent Treasurer Bertrand Tombal Chair, Clinical Research Division Christian Dittrich Chair, Translational Research Division Malcolm Mason Chair, Independent Data Monitoring Committee Mogens Groenvold Chair, Membership Committee Jean-Pierre Bizzari Chair, New Drug Advisory Committee Frances Shepherd Chair, Protocol Review Committee Lisa Licitra Chair, Quality Assurance Committee Sabine Tejpar Chair, Translational Research Advisory Committee Ian Tannock, Chair, SAC (until 30 june 2016) Elizabeth Eisenhauer, Chair, SAC (as of July 1st, 2016) Fatima Cardoso Member Serge Evrard Member Winette van der Graaf Member Denis Lacombe Director General, EORTC Françoise Meunier Director Special Projects, EORTC Alexander Eggermont Editor-in-Chief, European Journal of Cancer Jean-Claude Horiot EJC Liaison Officer 46 | EORTC at a glance Ex-officio members (non-voting) Diego du Monceau Chairman, EORTC Cancer Research Fund Victoria Agnew Director, EORTC Cancer Research Fund EORTC Research Groups and Task Forces Comprise scientists and/or clinicians organized in two divisions Clinical Research Division * Clinical Research Division B. Tombal Genito-Urinary Cancers S. Gillessen Brain Tumor M. Weller Breast Cancer F. Cardoso Cancer in the Elderly A. Luciani Cutaneous Lymphoma P. Quaglino Endocrine Tumors M. Schlumberger Gastrointestinal Tract Cancer M. Ducreux Gynecological Cancer P. Ottevanger Head and Neck Cancer V. Grégoire Infectious Diseases P. Donnelly Leukemia F. Baron Lung Cancer B. Besse Lymphoma M. Hutchings Melanoma C. Robert Children’s Leukemia Y. Benoit Quality of Life L. Van De Poll-Franse Radiation Oncology W. Budach Soft Tissue and Bone Sarcoma A. Gronchi Translational Research Division * * Chairs of the divisions Translational Research Division C. Dittrich PathoBiology J. Martens Imaging P. Bourguet Pharmacology and Molecular Mechanisms Group E. Raymond EORTC at a glance | 47 Representatives of the top 15 recruiting institutions U.Z. Leuven, Leuven (BE) P. Schöffski Erasmus MC, Rotterdam (NL) S. Sleijfer Institut Gustave Roussy, Villejuif (FR) M. Ducreux Hôpitaux Universitaires Bordet-Erasme, Brussels (BE) A. Awada CHRU de Lille, Lille (FR) F. Mazingue The Christie NHS Foundation Trust, Manchester (GB) C. Faivre-Finn Universitaetsklinikum Heidelberg, Heidelberg (DE) M. Platten Cliniques Universitaires Saint-Luc, Brussels (BE) JP. Machiels 48 | EORTC at a glance Radboud University Medical Center Nijmegen, Nijmegen (NL) C. van Herpen Ospedale Bellaria, Bologna (IT) A. Brandes Royal Marsden Hospital, London (GB) W. van der Graaf Institut Catala d’Oncologia, L’Hospitalet Hospital Duran i Reynals, Barcelona (ES) R. Salazar Centre Hospitalier Universitaire Vaudois, Lausanne (CH) D. Wagner CHU de Lyon, Institut d’Hematologie et d’Oncologie Pediatrique, Lyon (FR) Universitair Ziekenhuis Gent, Gent (BE) Y. Benoit EORTC HQ Directors Supports the operational aspects of clinical research implements sound scientific strategy in concert with the EORTC Groups Jan Bogaerts, PhD Methodology Director Denis Lacombe, MD, MSc Director General Vassilis Golfinopoulos, MD, PhD Medical Director Jan Bogaerts oversees operational and methodological aspects associated with the conduct of EORTC’s international clinical studies. Denis Lacombe is involved in the coordination and administration of all EORTC activities in order to promote the EORTC as a major European organization in Cancer Clinical and Translational Research. Dr. Lacombe is responsible for the organization of scientific activities, public relations, and strategies as defined by the EORTC Board as well as for internal and external communications. Dr. Vassilis Golfinopoulos oversees the development and implementation of the EORTC’s scientific strategy and support of initiatives put forth by the EORTC Board. Christian Brunet, MA Chief Financial Officer Françoise Meunier, MD, PhD, FRCP Director of the Special Projects John Winston Director of Development Christian Brunet is head of the Accounting & Finance and Contracts & Budget Departments, and supervises finance-related processes within EORTC. Françoise Meunier served as EORTC Director General from 1991 through 2015. Now EORTC Director Special Projects, she is a driving force behind the EORTC cancer survivorship initiatives and fundraising projects. Dr. Meunier sits on the EORTC Cancer Research Fund Board. John Winston steers international development and fundraising for EORTC, raising its profile and growing its appeal to individual, corporate and foundation supporters. EORTC at a glance | 49 EORTC HQ Coordination Committee The senior management team of EORTC Headquarters Denis Lacombe Director General Christian Brunet Chief Financial Officer Jan Bogaerts Methodology Director A. Marinus Clinical Operations Department Project Management and CTA Unit Regulatory Affairs Unit L. Collette Statistics & Independent Data Monitoring Committee S. Marréaud Medical & Pharmacovigilance Unit Fellowship P. Ruyskart IT Y. Liu Translational Research, Radiotherapy & Imaging C. Gilotay Data Management 50 | EORTC at a glance A. Bottomley Quality of Life EORTC Past Presidents JY. Blay, FR (2009-2012) M. Piccart, BE (2006-2009) A.M.M. Eggermont, FR (2003-2006) A.T. van Oosterom, BE (2000-2003) JC. Horiot, FR (1997-2000) G. McVie, UK (1994-1997) E. van der Schueren, BE (1991-1994) L. Denis, BE (1988-1991) U. Veronesi, IT (1985-1988) C. G. Schmidt, DE (1981-1984) L. G. Latja, UK (1979-1981) H. Tagnon, BE (1975-1978) D. W. van Bekkum, NL (1969-1975) S. Garattini, IT (1965-1968) G. Mathé, FR (1962-1965) EORTC at a glance | 51 Avenue E. Mounier 83/11 1200 Brussels, Belgium T: +32 2 774 16 11 www.eortc.org • [email protected]