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The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology

机译:FDA NIH生物肿瘤学中的生物标志物,EndpointS和其他工具(BEST)资源

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摘要

In early 2016, the FDA and the National Institutes of Health (NIH) published the first version of the glossary included in the Biomarkers, EndpointS, and other Tools (BEST) resource. 1 The BEST glossary was constructed to harmonize and clarify terms used in translational science and medical product development and to provide a common language used for communication by those agencies. It is considered a "living" document that will be updated in the future. This review will discuss the main biomarker and clinical outcome categories contained in the BEST glossary as they apply to neuro-oncology, as well as the overlapping and hierarchical relationships among them.
机译:2016年初,FDA和美国国立卫生研究院(NIH)发布了生物标志物,EndpointS和其他工具(BEST)资源中包含的词汇表的第一版。 1 BEST词汇表旨在协调和阐明翻译科学和医疗产品开发中使用的术语,并提供这些机构进行交流所使用的通用语言。它被认为是“现成的”文档,将来会更新。这篇综述将讨论BEST词汇表中包含的主要生物标志物和临床结果类别,因为它们适用于神经肿瘤学,以及它们之间的重叠和层次关系。

著录项

  • 来源
    《Neuro-Oncology》 |2018年第9期|1162-1172|共11页
  • 作者单位

    Harvard Med Sch, Dana Farber Brigham & Womens Canc Ctr, Dept Radiat Oncol, Boston, MA USA;

    US FDA, Off Hematol & Oncol Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA;

    Harvard Med Sch, Brigham & Womens Hosp, Dept Radiol, Boston, MA USA;

    Harvard Med Sch, Brigham & Womens Hosp, Dept Pathol, Boston, MA USA;

    Harvard Med Sch, Dana Farber Brigham & Womens Canc Ctr, Ctr Neurooncol, Boston, MA USA;

    Harvard Med Sch, Dana Farber Brigham & Womens Canc Ctr, Dept Radiat Oncol, Boston, MA USA;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

    BEST glossary; biomarkers; endpoints; glioma; outcomes;

    机译:最佳词汇表;生物标志物;终点;神经胶质瘤;结果;

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