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Leveraging external data in the design and analysis of clinical trials in neuro-oncology
The Lancet Oncology ( IF 51.1 ) Pub Date : 2021-09-27 , DOI: 10.1016/s1470-2045(21)00488-5
Rifaquat Rahman 1 , Steffen Ventz 2 , Jon McDunn 3 , Bill Louv 3 , Irmarie Reyes-Rivera 4 , Mei-Yin C Polley 5 , Fahar Merchant 6 , Lauren E Abrey 7 , Joshua E Allen 8 , Laura K Aguilar 9 , Estuardo Aguilar-Cordova 9 , David Arons 10 , Kirk Tanner 10 , Stephen Bagley 11 , Mustafa Khasraw 12 , Timothy Cloughesy 13 , Patrick Y Wen 14 , Brian M Alexander 15 , Lorenzo Trippa 2
Affiliation  

Integration of external control data, with patient-level information, in clinical trials has the potential to accelerate the development of new treatments in neuro-oncology by contextualising single-arm studies and improving decision making (eg, early stopping decisions). Based on a series of presentations at the 2020 Clinical Trials Think Tank hosted by the Society of Neuro-Oncology, we provide an overview on the use of external control data representative of the standard of care in the design and analysis of clinical trials. High-quality patient-level records, rigorous methods, and validation analyses are necessary to effectively leverage external data. We review study designs, statistical methods, risks, and potential distortions in using external data from completed trials and real-world data, as well as data sources, data sharing models, ongoing work, and applications in glioblastoma.



中文翻译:

利用外部数据设计和分析神经肿瘤学临床试验

在临床试验中将外部控制数据与患者层面的信息相整合,有可能通过单组研究的背景和改进决策(例如早期停止决策)来加速神经肿瘤学新疗法的开发。根据神经肿瘤学会主办的 2020 年临床试验智库的一系列演讲,我们概述了在临床试验的设计和分析中代表护理标准的外部控制数据的使用。高质量的患者记录、严格的方法和验证分析对于有效利用外部数据是必要的。我们回顾了研究设计、统计方法、风险和使用来自已完成试验的外部数据和真实世界数据的潜在扭曲,以及数据源、数据共享模型、正在进行的工作和在胶质母细胞瘤中的应用。

更新日期:2021-09-28
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