加速肿瘤药物开发的未来:联盟在提供精确肿瘤早期临床试验中的作用。

IF 42.1 1区 医学 Q1 ONCOLOGY
Journal of Clinical Oncology Pub Date : 2025-02-20 Epub Date: 2025-01-14 DOI:10.1200/JCO-24-01534
Jia Liu, Max Farrow, Lesley Seymour, Jayesh Desai, Herbert H Loong, Percy Ivy, Takafumi Koyoma, Natalie Cook, Sarah Blagden, Elena Garralda, Christophe Massard, Anthony W Tolcher, Jacob J Adashek, Li Zhang, Shen Zhao, Lin Shen, Razelle Kurzrock, Wafik S El-Deiry, Vivek Subbiah, Anthony M Joshua
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引用次数: 0

摘要

目的:在过去的15年中,早期临床试验(epct)的前景在数量和复杂性方面都经历了显着的扩张。地点、试验、赞助商和合同研究组织的激增呈指数级增长,标志着研究行为的重大转变。然而,EPCT操作存在许多效率低下的问题,例如繁琐的启动程序,这在需要及时确定药物安全性和推荐的II期剂量时尤为重要。网络和联盟可以克服招募合适患者和简化启动过程中的一些挑战,特别是当距离和疾病轨迹起作用时。设计:在这篇文章中,我们通过对文献和雪球抽样方法的系统回顾,概述了不同大洲成人肿瘤学的EPCT联盟。我们说明了它们的范围、结构、资金和成就。结果:确定了15个EPCT联盟,其中2个在美国,3个在欧洲,5个在亚太地区,2个洲际联盟,3个在私人肿瘤网络中。这些联盟的范围、资金和结构各不相同,从政府资助的模式,如国家癌症研究所实验治疗临床试验网络,到慈善机构资助和私人研究组织。EPCT联盟在合作研究中发挥作用,分子肿瘤委员会提供以患者为中心的生物标志物匹配治疗,并简化试验进行以改善时间表和成本效率。结论:EPCT活性和复杂性的增加导致了全球EPCT联盟数量的扩大。通过积极参与监管机构、制药和合同研究组织行业,联盟有机会解决该领域面临的不断发展的挑战,并加速科学发现转化为临床实践。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Accelerating the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials.

Purpose: Over the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner. Networks and consortia may overcome some of these challenges of enrolling suitable patients and streamlining start-up, particularly when distance and disease trajectory come into play.

Design: In this article, we provide an overview of EPCT consortia in adult oncology across different continents assembled through systematic review of the literature and snowball sampling methodology. We illustrate their scope, structure, funding, and achievements.

Results: Fifteen EPCT consortia were identified including two in the United States, three in Europe, five in Asia-Pacific, two intercontinental consortia, and three within private oncology networks. These consortia vary in their scope, funding, and structure from government-funded models such as the National Cancer Institute Experimental Therapeutics Clinical Trials Networks through charitably funded and private research organizations. EPCT consortia play a role in collaborative research, molecular tumor boards to provide patient-centric biomarker-matched treatments, and streamlining trial conduct to improve timelines and cost efficiency.

Conclusion: The growth in EPCT activity and complexity has resulted in expansion in the number of EPCT consortia globally. By actively engaging with regulatory bodies and pharmaceutical and contract research organization industries, consortia have an opportunity to address the evolving challenges faced in this field and to accelerate the translation of scientific discoveries into clinical practice.

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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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