我们需要什么样的证据来确证生物标志物？
What evidence do we need for biomarker qualification?
机构信息
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA.
出版信息
Sci Transl Med. 2017 Nov 22;9(417). doi: 10.1126/scitranslmed.aal4599.
Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.
生物标志物可以促进药物研发过程的各个方面。然而，生物标志物的鉴定（即美国食品和药物管理局认可的生物标志物的使用）需要一个清晰、可预测的过程。我们描述了一个包括政府、行业和学术界在内的多方利益相关者的努力，提出了一个定义生物标志物鉴定所需证据量的框架。该框架旨在广泛应用于多个生物标志物类别和用途。
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