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Basket Studies: Redefining Clinical Trials in the Era of Genome-Driven Oncology.
Annual Review of Medicine ( IF 10.5 ) Pub Date : 2018-01-29 00:00:00 , DOI: 10.1146/annurev-med-062016-050343
Jessica J Tao 1 , Alison M Schram 1 , David M Hyman 1, 2
Affiliation  

Understanding a tumor's detailed molecular profile has become increasingly necessary to deliver the standard of care for patients with advanced cancer. Innovations in both tumor genomic sequencing technology and the development of drugs that target molecular alterations have fueled recent gains in genome-driven oncology care. “Basket studies,” or histology-agnostic clinical trials in genomically selected patients, represent one important research tool to continue making progress in this field. We review key aspects of genome-driven oncology care, including the purpose and utility of basket studies, biostatistical considerations in trial design, genomic knowledgebase development, and patient matching and enrollment models, which are critical for translating our genomic knowledge into clinically meaningful outcomes.

中文翻译:


篮子研究:在基因组驱动的肿瘤学时代重新定义临床试验。

为了为晚期癌症患者提供标准的治疗,越来越需要了解肿瘤的详细分子特征。肿瘤基因组测序技术的创新和靶向分子改变的药物的开发都推动了基因组驱动的肿瘤学护理领域的最新发展。在基因组选择的患者中,“篮子研究”或与组织学无关的临床试验是继续在该领域取得进展的一种重要研究工具。我们审查了基因组驱动的肿瘤学护理的关键方面,包括篮子研究的目的和用途,试验设计中的生物统计学考虑,基因组知识库的开发以及患者匹配和入院模型,这些对于将我们的基因组学知识转化为具有临床意义的结果至关重要。

更新日期:2018-01-29
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