The first European multi-stakeholder model to address biomarker based drug development and promote innovative partnership successfully gathered in Brussels on 07 November 2013. The meeting convened circa 80 selected representatives of patient groups, academic researchers, regulators, government, European Union commission, pharmaceutical industry sector, and diagnostic and technology companies alongside EORTC officers and representatives.
Without a doubt, the overall success and economic viability of cancer clinical research will soon depend on data driven outcomes mandating data integration and collaboration among various stakeholders. This trend will have an indelible impact on the clinical research strategic agenda, clinical research business models, and the interaction pattern of clinical research stakeholders. In this light, the first EORTC Screening Program for Efficient Clinical Trial Access (SPECTA) forum took place in order to engage the active participation and contribution of multiple partners in a new collaborative business model for developing improved treatments for patients with cancer.
SPECTAforum is an essential component of EORTC’s SPECTAprogram, an integrated and cost sharing business model for cancer clinical research and development aiming at “Screen and Treat”. SPECTA comprises a network of participating clinical sites and screening platforms that can screen individual patients for multiple molecular targets and potentially allow the design of trials that will match the specific biology of the diseases affecting specific patients with cancer.
Dr. Denis Lacombe, EORTC Headquarters Director, emphasizes, “SPECTAforum ensures that each partner derives benefit from doing business with the others. In essence, SPECTA is a multi-stakeholder partnership in which all parties are active players. We foresee that through SPECTAforum active projects will be brought to the program and new routes will be established to efficiently tackle the challenges of current drug development.”
The benefits of this innovative model include efficient patient selection and access, quality assurance and control, new partnership models, alignment of efforts, access to new technologies, biomarker qualification and validation, and cost efficiency and sharing. SPECTA addresses the efficacy/effectiveness gap which hinders current clinical research.
Current platforms within SPECTA include SPECTAcolor for colorectal cancer, SPECTAbrain for central nervous system cancers, SPECTAmel for melanoma, SPECTAlung for lung cancer, and SPECTAprostate for prostate cancer. These platforms facilitate clinical trial access based on systematic, coordinated and quality controlled tumor tissue collection and analysis platforms dedicated to patients with cancer. Additional platforms are in development.
SPECTAcolor, the first of these platforms, has recently been launched. It will run in 25 clinical centers located in ten European countries: Belgium, Cyprus, France, Germany, Greece, Italy, Portugal, Spain, Sweden, and Switzerland. Patients with colorectal cancer are being enrolled and samples from their primary tumor and/or metastatic site(s) are being tested for mutations in colorectal cancer biomarkers. Partnership between the EORTC PathoBiology Group and the European Society of Pathology allows adoption of best practices and standardized procedures for histopathology review and human biological material handling.
Adult patients with pathologically confirmed locally advanced (TxN2; T4N1) or metastatic colorectal cancer with no more than two previous palliative lines of treatment are invited to give their informed consent to test for mutations in colorectal cancer biomarkers, i.e., in KRAS, BRAF, NRAS, MSI, and PI3K, of their primary tumor and/or the metastatic site(s). Circa 360 cancer genes will also be tested for research purposes using Next Generation Sequencing in cooperation with the Wellcome Trust Sanger Institute and used to further segregate these patients into disease subgroups. The primary endpoint of SPECTAcolor is to test for these molecular markers in patients whom are likely to be enrolled in downstream biomarker-led clinical trials.
John Bean, PhD
EORTC, Medical Science Writer