Integrating collection of biospecimens in clinical trials: the approach of the European organization for research and treatment of cancer.

Abstract

Access to biospecimens and their derivatives, that is, human biological materials (HBM), for translational research (TR) is considered a major bottleneck hindering successful bench to bedside translation. Clinical trials offer a unique opportunity to collect HBM in a specialized setting that allows prospectively designed, high-quality TR that would be difficult to fulfill from community- or population-based HBM collections alone. Increasingly, as the field advances toward personalized treatment of cancer patients, access to HBM is becoming a necessity for patient enrollment in a new generation of clinical studies that are designed and driven by molecular hypotheses. The European Organization for Research and Treatment of Cancer (EORTC) is one of the largest networks for clinical trials in oncology. The EORTC is re-focusing its strategy, building on experiences and expertise gained over the years from specific initiatives such as EORTC Group activities and the EORTC Virtual Tumour Bank, by developing new mechanisms to support investigators with the practical aspects of HBM collection as part of EORTC clinical studies. Due to the complex, multidisciplinary nature of HBM collection and TR, integration of HBM collection into clinical trials warrants careful upfront planning and input from a range of expertise. To simplify HBM collection in clinical studies, the EORTC has developed a simple checklist containing the key elements of HBM collection setup and combines these into a simple tool for practical use. Through identifying and managing key risk areas, this can maximize the HBM collection success while achieving efficient clinical trial development. This article focuses on the key elements of HBM collection and the approaches of the EORTC for efficiently integrating this collection into clinical trial development.