{"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.