Real-World Data for the Drug Development in the Digital Era

Xianchen Liu
{"title":"Real-World Data for the Drug Development in the Digital Era","authors":"Xianchen Liu","doi":"10.37965/jait.2022.0091","DOIUrl":null,"url":null,"abstract":"Randomized clinical trials (RCTs) have long been recognized the gold standard for regulatory approval in the drug development. However, RCTs may not be feasible in some diseases and/or under certain situations and findings from RCTs may not be generalized to real-world patients in the routine clinical practice. Real-world evidence (RWE) generated from various real-world data has become more and more important for the drug development and clinical decision making in the digital era. This paper described real-world data, RWE, and RWE generation, followed by the characteristics and differences between RCTs and RWE studies. Furthermore, the challenges and limitations of real-world data and RWE studies were discussed.","PeriodicalId":70996,"journal":{"name":"人工智能技术学报(英文)","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"9","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"人工智能技术学报(英文)","FirstCategoryId":"1093","ListUrlMain":"https://doi.org/10.37965/jait.2022.0091","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 9

Abstract

Randomized clinical trials (RCTs) have long been recognized the gold standard for regulatory approval in the drug development. However, RCTs may not be feasible in some diseases and/or under certain situations and findings from RCTs may not be generalized to real-world patients in the routine clinical practice. Real-world evidence (RWE) generated from various real-world data has become more and more important for the drug development and clinical decision making in the digital era. This paper described real-world data, RWE, and RWE generation, followed by the characteristics and differences between RCTs and RWE studies. Furthermore, the challenges and limitations of real-world data and RWE studies were discussed.
数字时代药物开发的真实世界数据
随机临床试验(RCT)长期以来一直被公认为药物开发中监管批准的金标准。然而,随机对照试验在某些疾病和/或某些情况下可能不可行,并且在常规临床实践中,随机对照研究的结果可能无法推广到真实世界的患者。从各种真实世界数据中生成的真实世界证据(RWE)在数字时代的药物开发和临床决策中变得越来越重要。本文描述了真实世界的数据、RWE和RWE生成,以及随机对照试验和RWE研究之间的特点和差异。此外,还讨论了真实世界数据和RWE研究的挑战和局限性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
8.70
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信