The use of real-world data in drug repurposing.

IF 1.1 Q4 PHARMACOLOGY & PHARMACY Translational and Clinical Pharmacology Pub Date : 2021-09-01 Epub Date: 2021-09-27 DOI:10.12793/tcp.2021.29.e18
Kyungsoo Park
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引用次数: 4

Abstract

Drug repurposing, or repositioning, is to identify new uses for existing drugs. Significantly reducing the costs and time-to-market of a medication, drug repurposing has been an alternative tool to accelerate drug development process. On the other hand, 'real world data (RWD)' has been also increasingly used to support drug development process owing to its better representing actual pattern of drug treatment and outcome in real world. In the healthcare domain, RWD refers to data collected from sources other than traditional clinical trials; for example, in electronic health records or claims and billing data. With the enactment of the 21st Century Cures Act, which encourages the use of RWD in drug development and repurposing as well, such increasing trend in RWD use will be expedited. In this context, this review provides an overview of recent progresses in the area of drug repurposing where RWD was used by firstly introducing the increasing trend and regulatory change in the use of RWD in drug development, secondly reviewing published works using RWD in drug repurposing, classifying them in the repurposing strategy, and lastly addressing limitations and advantages of RWDs.

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真实世界数据在药物再利用中的应用。
药物再利用或重新定位是为现有药物确定新的用途。药物再利用大大降低了药物的成本和上市时间,已经成为加速药物开发过程的另一种工具。另一方面,“真实世界数据(RWD)”也越来越多地用于支持药物开发过程,因为它更好地代表了现实世界中药物治疗的实际模式和结果。在医疗保健领域,RWD是指从传统临床试验以外的来源收集的数据;例如,在电子健康记录或索赔和账单数据中。随着《21世纪治愈法案》的颁布,鼓励在药物开发和再利用中使用RWD, RWD的使用将加速这种增长趋势。在此背景下,本文综述了RWD在药物再利用领域的最新进展,首先介绍了RWD在药物开发中使用的增长趋势和监管变化,其次回顾了已发表的RWD在药物再利用中的研究成果,并对其进行了分类,最后阐述了RWD在药物再利用中的局限性和优势。
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来源期刊
Translational and Clinical Pharmacology
Translational and Clinical Pharmacology Medicine-Pharmacology (medical)
CiteScore
1.60
自引率
11.10%
发文量
17
期刊介绍: Translational and Clinical Pharmacology (Transl Clin Pharmacol, TCP) is the official journal of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT). TCP is an interdisciplinary journal devoted to the dissemination of knowledge relating to all aspects of translational and clinical pharmacology. The categories for publication include pharmacokinetics (PK) and drug disposition, drug metabolism, pharmacodynamics (PD), clinical trials and design issues, pharmacogenomics and pharmacogenetics, pharmacometrics, pharmacoepidemiology, pharmacovigilence, and human pharmacology. Studies involving animal models, pharmacological characterization, and clinical trials are appropriate for consideration.
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