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Integrating Collection of Biospecimens in Clinical Trials: The Approach of the European Organization for Research and Treatment of Cancer

机译：在临床试验中整合生物标本的收集：欧洲癌症研究与治疗组织的方法

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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, highquality 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.
机译：获得生物标本及其衍生物，即人类生物材料（HBM），进行翻译研究（TR），被认为是阻碍从板凳到床边翻译成功的主要瓶颈。临床试验提供了一个独特的机会，可以在专门的环境中收集HBM，从而可以实现仅通过社区或人群为基础的HBM收集很难实现的前瞻性设计的高质量TR。随着该领域朝着对癌症患者进行个性化治疗的方向发展，获得HBM成为患者参与由分子假设设计和驱动的新一代临床研究的必要条件。欧洲癌症研究与治疗组织（EORTC）是最大的肿瘤学临床试验网络之一。 EORTC正在根据过去几年从EORTC集团活动和EORTC虚拟肿瘤银行等特定计划中获得的经验和专业知识，通过开发新的机制来支持研究人员，将HBM收集的实际情况作为支持，来重新调整其战略重点。 EORTC临床研究。由于HBM收集和TR的复杂性和多学科性质，将HBM收集整合到临床试验中需要进行认真的前期计划和各种专业知识的投入。为了简化临床研究中的HBM收集，EORTC开发了一个简单的清单，其中包含HBM收集设置的关键要素，并将这些要素组合成一个实用的简单工具。通过识别和管理关键风险区域，这可以最大程度地提高HBM收集的成功率，同时实现有效的临床试验开发。本文重点介绍HBM收集的关键要素和EORTC的方法，以将其有效整合到临床试验开发中。

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