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肿瘤学试验中的多学科质量保证与控制:欧洲癌症研究与治疗组织(EORTC)的观点

Multidisciplinary quality assurance and control in oncological trials: Perspectives from European Organisation for Research and Treatment of Cancer (EORTC).

出版信息

Eur J Cancer. 2017 Nov;86:91-100. doi: 10.1016/j.ejca.2017.07.039. Epub 2017 Sep 29.

Abstract

Quality assurance (QA) programmes are one of the mainstays of clinical research and constitute the pillars on which European Organisation for Research Treatment of Cancer (EORTC) delivers multidisciplinary therapeutic progress. Changing practice treatments require solid evidence-based data, which can only be achieved if integral QA is part of the infrastructure sustaining research projects. Cancer treatment is a multimodality approach, which is often applied either in sequence and/or in combination. Each modality plays a key role in cancer control. The modalities by which QA is applied varies substantially within and across the disciplines. In addition, translational and diagnostic disciplines take an increasing role in the era of precision medicine. Building on the structuring effect of clinical research with fully integrated multidisciplinary QA programmes associated with the solutions addressing the chain of custody for biological material and data integrity as well as compliance ensure at the same time validity of clinical research output but also have a training effect on health care providers, who are more likely to apply such principles as routine. The principles of QA are therefore critical to be embedded in multidisciplinary infrastructure to guarantee therapeutic progress. These principles also provide the basis for the functioning of multidisciplinary tumour board. However, technical, operational and economic challenges which go with the implementation of such programmes require optimal know-how and the coordination of the multiple expertise and such efforts are best achieved through centralised infrastructure.

摘要

质量保证(QA)计划是临床研究的主要支柱之一,构成了欧洲癌症研究与治疗组织(EORTC)实现多学科治疗进展的支柱。改变实践治疗方法需要可靠的循证数据,只有将完整的质量保证作为维持研究项目的基础设施的一部分,才能实现这一点。癌症治疗是一种多模式方法,通常按顺序和/或联合应用。每种模式在癌症控制中都起着关键作用。质量保证的应用方式在各学科内部和之间有很大差异。此外,在精准医学时代,转化医学和诊断学科发挥着越来越重要的作用。基于临床研究的结构化效应,通过与解决生物材料保管链、数据完整性以及合规性问题的解决方案相关联的全面整合的多学科质量保证计划,不仅能确保临床研究成果的有效性,还能对医疗保健提供者产生培训效果,使他们更有可能将这些原则作为常规应用。因此,质量保证原则对于融入多学科基础设施以保证治疗进展至关重要。这些原则也为多学科肿瘤委员会的运作提供了基础。然而,实施此类计划所面临的技术、操作和经济挑战需要最佳的专业知识以及多种专业技能的协调,而通过集中式基础设施能最好地实现这些努力。

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