利用生物标志物和辅助诊断快速开发药物

IF 1.4 Q4 ONCOLOGY
Noreen McBrearty, Devika Bahal, S. Platero
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引用次数: 0

摘要

要全面实施精准医疗,需要深入了解生物标记物、伴随诊断及其在临床试验中的应用。在此,我们将介绍生物标记物发现和临床试验设计中的关键事件,以及如何简化这些阶段以快速批准伴随诊断(CDx)。我们讨论了成功的 CDx 所应具备的关键品质,其中包括了解标记物在意向治疗人群中的流行率、仔细考虑将在后期临床试验阶段使用的评分方案、CDx 性能的可靠性以及其他必要特征。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Fast-tracking drug development with biomarkers and companion diagnostics
To fully implement precision medicine, a deeper understanding of biomarkers, companion diagnostics, and their use in clinical trials is needed. Here, we describe key events in biomarker discovery and clinical trial design, and how those stages may be streamlined to fast-track approval of companion diagnostics (CDx). We discuss crucial qualities of a successful CDx that include understanding the prevalence of the marker in the intention to treat population, careful consideration of the scoring scheme that will be used in later clinical trial stages, and reliability of the performance of the CDx, in addition to other necessary features.
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来源期刊
CiteScore
3.20
自引率
5.30%
发文量
460
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