临床试验困境：从基于生物标记的药物开发中汲取的经验教训

IF 48.8 1区医学 Q1 CELL BIOLOGY

Cancer Cell Pub Date : 2024-06-10 DOI:10.1016/j.ccell.2024.05.014

Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, Olga Kholmanskikh Van Criekingen, Simone Koole, David M. Thomas, Hans Gelderblom

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引用次数: 0

摘要

目前已开发出基于不同生物标志物的各种检测方法，以确定接受聚（ADP-核糖）聚合酶（PARP）抑制剂治疗的最佳候选者。然而，由于这些复杂的生物标志物缺乏统一性，再加上不同的截断点和未知的时空变化，很难确定每种检测方法的临床效用并确保治疗决策的统一性。在此，我们提出了统一生物标志物定义和诊断的最低分析性能特征的措施，以确保公平、可持续地获得精准医疗。

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Testing dilemmas in the clinic: Lessons learned from biomarker-based drug development

Various tests based on different biomarkers have been developed to identify the best candidates for poly(ADP-ribose) polymerase (PARP)-inhibitor therapy. However, due to the absence of harmonization regarding these complex biomarkers, along with various cutoff points and unknown spatial and temporal variations, it is difficult to define the clinical utility of each test and ensure uniformity in treatment decision-making. Here, we propose measures to align biomarker definitions and minimum analytical performance characteristics for diagnostics to ensure equitable and sustainable access to precision medicine.

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来源期刊

Cancer Cell 医学-肿瘤学

CiteScore

55.20

自引率

1.20%

发文量

179

审稿时长

4-8 weeks

期刊介绍： Cancer Cell is a journal that focuses on promoting major advances in cancer research and oncology. The primary criteria for considering manuscripts are as follows: Major advances: Manuscripts should provide significant advancements in answering important questions related to naturally occurring cancers. Translational research: The journal welcomes translational research, which involves the application of basic scientific findings to human health and clinical practice. Clinical investigations: Cancer Cell is interested in publishing clinical investigations that contribute to establishing new paradigms in the treatment, diagnosis, or prevention of cancers. Insights into cancer biology: The journal values clinical investigations that provide important insights into cancer biology beyond what has been revealed by preclinical studies. Mechanism-based proof-of-principle studies: Cancer Cell encourages the publication of mechanism-based proof-of-principle clinical studies, which demonstrate the feasibility of a specific therapeutic approach or diagnostic test.