The EORTC is the only European organization that unites European cancer experts from all disciplines to establish international collaborations that facilitate, accelerate, conduct, and coordinate independent clinical and translational research on all types of cancer. The structure and functioning of EORTC Headquarters reflect the need to support its mission and provide expertise over a broad range of activities and research areas from strategic development to publication of research results.
Not only does EORTC Headquarters support the operational aspects of clinical research through protocol development, data and project management, regulatory affairs, and pharmacovigilance, but over the years EORTC Headquarters has become the essential partner of the EORTC Groups in implementing sound scientific strategy. This is achieved through expertise provided by the:
- Statistics Department;
- Medical Department;
- Translational Research, Radiotherapy, and Imaging Department.
Additionally, the Quality of Life Department develops and analyzes the quality of Life component of EORTC trials, the Early Project Optimization Department (EPOD) supports the development of the strategies for upcoming projects, and the Fellowship Program serves a unique role in supporting data optimization and utilization while simultaneously providing valuable training to young oncologists.
Over the years, EORTC headquarters has supported a large number of clinical trials addressing early and late stage development scientific questions as well as a number of scientific and methodological research projects.
As of 2014, with 174 staff members (112 females and 62 males), EORTC Headquarters is fully equipped to organize and conduct clinical research activities according to today standards guided by a set of fully auditable procedures and policies. EORTC Headquarters is also active in educational activities through a number of courses and symposia dedicated mostly to the methodology and implementation of clinical research.
Implementation of the EORTC Scientific Strategy
The EORTC scientific strategy as defined and approved by the EORTC Board continually evolves in response to the changing needs of the cancer clinical trial landscape. EORTC Headquarters is confronted with a rapidly changing environment and needs to assess why and how certain activities are performed. In the past ten years the main parameters which have had a profound impact on the organization and its functioning are:
- Implementation of molecular biology for personalized medicine;
- Evolution of the European regulatory framework;
- Expanding intergroup cooperation;
- Increased partnerships with other learned societies such as with those in imaging and pathology.
In response to the above, the EORTC scientific strategy is now centered on clinical research questions which require not only an international and multi-disciplinary set up but also require the integration of biology, pathology and imaging. This has all been done in order to optimally develop therapeutic strategies with a more complete understanding of the biology of the diseases and the mechanisms of action of the therapeutic interventions; our aim is to apply the appropriate treatment to the right patient at the required time.
The EORTC Scientific Strategy now sustained by EORTC based technical expertise platforms
The implementation of new clinical research approaches would not be possible without innovative support which integrates knowledge gained from biology and imaging. A challenge, therefore, is to successfully integrate clinical, pathobiological and imaging data to gain an optimal understanding of the biology of the disease and to support development and therapeutic decisions.
To achieve such goals, EORTC Headquarters now has an imaging platform which allows upload, central review and quality assurance of images in real time, regardless of whether these were obtained by radiology or nuclear medicine. In a similar spirit, new biobanking policies allow the development and conduct of a new generation of trials based on tissue acquisition and biomarker determination. This has been made possible by a close cooperation between the Information Technology Department and the Translational Research, Radiotherapy and ImagingDepartment. This expertise enabled EORTC Headquarters to successfully obtain support for a major Innovative Medicine Initiative project for the development of imaging biomarkers.
Modern clinical research cannot be addressed without specific partnerships
EORTC, and more specifically EORTC Headquarters, is now positioned as a unique international, European based clinical research organization. The current research landscape shows that what had been done by the organization independently for the past 50 years now requires additional and /or more structured cooperations and partnerships with other learned societies and with the pharmaceutical industry sector. 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 for rapid patient recruitment and more effective clinical/translational research.
Consequently, EORTC Headquarters has established partnerships for its imaging and tranalational research platforms, such as, but not limited to, the European Association for Nuclear Medicine, the European Society for Radiology, and the European Society for Pathology. These learned societies benefit from the EORTC’s expertise in clinical research, while the EORTC can implement complex programs taking into account all quality assurance parameters for the concerned disciplines.
The number of patients included in intergroup studies has been steadily increasing to the point where intergroup studies account for roughly one third of EORTC activities. Taken together with the complexity of the regulatory framework, this has prompted EORTC Headquarters to set up liaison offices in France, the United Kingdom, Poland, and Germany.
Cooperation with the pharmaceutical industry sector is a key to innovation
The EORTC has a series of trials which were successfully conducted in partnership with industry and which jointly changed practice. These serve either prospectively or retrospectively for drug registration which is in the best interest of all parties and leading to therapeutic improvement for patients.
Moving forward, new forms of partnerships between industry and academia will need to be envisioned as modern clinical trials demand long term maintenance of technical and cross validated infrastructure which is neither in the remit nor in the capacity of industry. New agents can be best and more rapidly developed if studied in such high quality academic environments. Molecular sub-division of tumor entities imposes the formation of efficient and transnational networks for large screening programs for complex trials which cannot be administered outside an optimally controlled and well-oiled infrastructure with the aim of avoiding duplication of screening efforts by industry.
Complementary commercial and academic 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, funding will remain a major challenge for complex, cutting edge clinical and translational research.
The EORTC has made substantial progress in facilitating interactions with industry for drug development. Today, the operations to conduct clinical trials and data exchange policies take into account the interests and needs of the partners.. That said, it is critical for both industry and academia, when partnering on trials which go beyond the single drug development approach, that the principles of academic independence are respected. The forms and the methods of cooperation with industry are constantly evolving but are based on a good balance between a few criteria ensuring academia independence and sets of procedures for full visibility by industry. EORTC clinical data based are CFR part 11 and CDISC compliant to facilitate partnerships with industry.
Working closely with patient organizations brings a critical eye to EORTC activities
The EORTC has established relationships with numerous patient organizations and cancer leagues throughout Europe. In these relationships, the EORTC benefits from the expertise of patients for making information sheets and informed consent forms more patient friendly and for the dissemination of information concerning progress in EORTC cancer clinical trials. Further insights on other forms of cooperation are being explored and a series of annual meetings with patient advocacy groups has been initiated in 2014. A number of continued activities have been revisited and upgraded. In addition, since 2012, EORTC has created an open forum for patient representatives to attend a one day introduction to EORTC studies.
The way forward
Roadmap for change: partnership
EORTC Headquarters has evolved to become a unique European clinical trial infrastructure with multifaceted functions which embraces all the challenges of modern cancer clinical research for the benefit of all patients with cancer.