Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States.

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2020-04-30 eCollection Date: 2020-01-01 DOI:10.2147/POR.S241427
Lisa M Hess, Michael Grabner, Liya Wang, Astra M Liepa, Xiaohong Ivy Li, Zhanglin Lin Cui, Lee Bowman, William R Schelman
{"title":"Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States.","authors":"Lisa M Hess,&nbsp;Michael Grabner,&nbsp;Liya Wang,&nbsp;Astra M Liepa,&nbsp;Xiaohong Ivy Li,&nbsp;Zhanglin Lin Cui,&nbsp;Lee Bowman,&nbsp;William R Schelman","doi":"10.2147/POR.S241427","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time.</p><p><strong>Methods: </strong>This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval.</p><p><strong>Results: </strong>Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58).</p><p><strong>Conclusion: </strong>Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"11 ","pages":"27-43"},"PeriodicalIF":2.3000,"publicationDate":"2020-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S241427","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pragmatic and Observational Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/POR.S241427","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 1

Abstract

Background: As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time.

Methods: This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval.

Results: Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58).

Conclusion: Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.

Abstract Image

Abstract Image

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
美国新近批准的晚期胃癌药物的真实世界数据早期分析结论的可靠性
背景:随着现实世界数据资源的扩展和完善,将有越来越多的机会研究干预措施的有效性。有必要确保研究设计探索潜在的偏见来源,并承认或减轻它们,以提高研究结果的准确性。本研究的目的是了解新批准的药物使用模式,在现实世界的临床设置随着时间的推移。方法:这项回顾性研究包括三个真实数据来源(索赔、电子健康记录和质量护理计划的重新编码数据),这些数据来自于曲妥珠单抗或拉穆单抗治疗的胃癌患者。线性回归用于调查自美国食品和药物管理局(FDA)批准以来这些药物用于胃癌患者护理的趋势。结果:符合条件的患者(n=1700)随时间的推移具有一致的人口统计学和临床特征。在获得监管批准后,曲妥珠单抗被用于较晚的治疗线,然后转移到较早的治疗线(p=0.002),而在FDA批准后,ramucirumab的使用一直保持一致(p=0.49)。Ramucirumab增强,定义为在开始一系列治疗后添加药物,随着时间的推移而减少(p=0.03),而曲妥珠单抗增强随时间保持一致(p=0.58)。结论:由于治疗效果可能在治疗线之间发生变化,如果在使用真实数据分析的时间段内药物使用发生变化(如线迁移),则可能产生偏倚。
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 去求助
来源期刊
Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
自引率
0.00%
发文量
11
期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
期刊最新文献
Improving the Transparency and Replicability of Consensus Methods: Respiratory Medicine as a Case Example. Non-Alcoholic Steatohepatitis Patient Characterization and Real-World Management Approaches in Italy. Comparing Machine Learning and Advanced Methods with Traditional Methods to Generate Weights in Inverse Probability of Treatment Weighting: The INFORM Study. Involvement of Root Canal Treatment in Pro-Inflammatory Processes - A Real-World Study. UK Electronic Healthcare Records for Research: A Scientometric Analysis of Respiratory, Cardiovascular, and COVID-19 Publications.
×
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
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 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 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1