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整合早期药物研发与临床网络:挑战与机遇——希望之城的发展经验

Integrating Early-Stage Drug Development with Clinical Networks; Challenges and Opportunities: The City of Hope Developing Experience.

作者信息

Villalona-Calero Miguel A, Malhotra Jyoti, Chung Vincent, Xing Yan, Gray Stacy W, Hampel Heather, Gruber Stephen, McDonnell Kevin

机构信息

City of Hope National Medical Center, Department of Medical Oncology, Duarte, CA 91010, USA.

出版信息

J Clin Med. 2023 Jun 15;12(12):4061. doi: 10.3390/jcm12124061.

DOI:10.3390/jcm12124061
PMID:37373756
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10299326/
Abstract

Recent data suggest that patients with advanced cancer who participate in biomarker/genomically informed early-stage clinical trials experience clinical benefit. While most early-stage clinical trials are conducted in major academic centers, the majority of cancer patients in the United States are treated in community practices. Here, we describe ongoing efforts at the City of Hope Cancer Center to integrate our network community oncology clinical practices into our academic, centralized biomarker/genomic-driven, early-stage clinical trial program to build an understanding of the approaches that provide the benefits of early-stage clinical trial participation to community patients. Our efforts include three key initiatives: the development of a virtual "Refractory Disease" phase 1 trial matching televideo clinic, the construction of infrastructure to support the expansion of phase 1 clinical trials to a distant regional clinical satellite hub, and the implementation of an enterprise-wide precision medicine, germline, and somatic testing program. Our work at City of Hope may serve as an example to facilitate similar efforts at other institutions.

摘要

近期数据表明,参与生物标志物/基因组信息指导的早期临床试验的晚期癌症患者可获得临床益处。虽然大多数早期临床试验在主要学术中心进行,但美国大多数癌症患者是在社区医疗机构接受治疗。在此,我们描述了希望之城癌症中心正在进行的努力,即将我们的网络社区肿瘤临床实践纳入我们学术性的、集中的生物标志物/基因组驱动的早期临床试验项目,以了解能让社区患者从参与早期临床试验中获益的方法。我们的努力包括三项关键举措:开发一个虚拟的“难治性疾病”1期试验匹配电视视频诊所,建设基础设施以支持将1期临床试验扩展到远程区域临床卫星中心,以及实施全企业范围的精准医学、种系和体细胞检测项目。我们在希望之城的工作可为其他机构推动类似努力提供范例。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c695/10299326/2eba3775502f/jcm-12-04061-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c695/10299326/6323de9a9ca6/jcm-12-04061-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c695/10299326/2eba3775502f/jcm-12-04061-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c695/10299326/6323de9a9ca6/jcm-12-04061-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c695/10299326/2eba3775502f/jcm-12-04061-g002.jpg

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本文引用的文献

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