European Perspective for Effective Cancer Drug Development and New Forms of Partnerships for Managing Uncertainty
The aims of the European Organisation for Research and Treatment of Cancer (EORTC) are to develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patient quality of life. Extensive and comprehensive research in this wide field is often beyond the means of individual European hospitals and can be best accomplished through the multidisciplinary multinational efforts of basic scientists and clinicians.
The ultimate goal of the EORTC is to improve the standard of cancer treatment through the testing of more effective therapeutic strategies based on drugs, surgery and/or radiotherapy that are already in use. The EORTC also contributes to the development of new drugs and other innovative approaches in partnership with the pharmaceutical industry. This is accomplished mainly by conducting large, multicenter, prospective, randomized, phase III clinical trials. In this way, the EORTC facilitates the passage of experimental discoveries into state of the art treatments.
Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices.
EORTC Headquarters, a unique pan European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.
The EORTC is both multinational and multidisciplinary, and the EORTC Network comprises over 300 hospitals and cancer centers in over 30 countries which include some 2,500 collaborators from all disciplines involved in cancer treatment and research.
The 170 members of the EORTC Headquarters staff handle some 6,000 new patients enrolled each year in cancer clinical trials, approximately 30 protocols that are permanently open to patient entry, over 50,000 patients who are in follow-up, and a database of more than 180,000 patients.
Health care systems and the clinical research landscape evolve continuously owing to increased risk aversion, scrutiny by funding bodies, and costs of clinical trials. In this context, however, current drug development procedures are far from optimal, as exemplified by the late-stage failure of several drugs. The identification of new drugs urgently requires approaches based on a solid understanding of cancer biology, and that will support the design of robust confirmatory trials. The complexity and the costs of drug development are now beyond the knowledge and operational capacity of single organisations, therefore, a drastic deviation from the traditional path of drug discovery and new forms of multidisciplinary partnerships are needed to succeed in this sector. The European Organisation for Research and Treatment of Cancer (EORTC) proposes the use of collaborative molecular screening platforms (CMSPs) as a new approach to tackle this issue. These CMSPs have the advantage of optimizing the expertise of several partners and combining efforts alongside with cost-sharing models for efficient patient selection.
EORTC has developed a CMSP called Screening Patients for Efficient Clinical Trials Access (SPECTA). The EORTC SPECTA is a European screening programme that aims to ensure efficient clinical trial access for patients with a range of tumour types. SPECTA is an integrated and cost-sharing model developed to address the described concerns relating to the current drug development process. This programme coordinates several SPECTA platforms on a pan-European level with the aim of identifying, at an early stage, specific druggable aberrations and, therefore, to offer specific targeted treatment to patients within clinical trials.
The SPECTA programme is a fully integrated business model that, as well as comprising disease‑oriented screening platforms also embeds specific initiatives to address both the regulatory challenges and the molecular pathological complexity of cancer. A collection of fora has been created for all stakeholders to meet and discuss for optimal mutualization of knowledge.
- SPECTApath is intended to address quality-assurance programmes across the disease platforms for optimal biomarker qualification and validation, and is crucial for the involvement of pathologists and molecular biologists.
- SPECTAreg is a research project that addresses the evolution of the forms of partnerships, looks into optimizing regulatory procedures for these new forms of clinical research and explores the routes to new forms of licensing.
SPECTA is now currently recruiting patients and EORTC is seeking partnership with the commercial sector to explore new models of drug development.