美国食品和药物管理局国立卫生研究院神经肿瘤学中的生物标志物、终点和其他工具（BEST）资源。
The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology.
机构信息
Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.
Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
出版信息
Neuro Oncol. 2018 Aug 2;20(9):1162-1172. doi: 10.1093/neuonc/nox242.
Abstract
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.
摘要
2016 年初，美国食品和药物管理局（FDA）和美国国立卫生研究院（NIH）发布了包含在生物标志物、终点和其他工具（BEST）资源中的词汇表的第一版。1 BEST 词汇表的构建旨在协调和澄清转化科学和医疗产品开发中使用的术语，并为这些机构的沟通提供共同语言。它被认为是一个“活”的文档，将在未来更新。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终点类别，以及它们在神经肿瘤学中的应用，以及它们之间的重叠和层次关系。
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