• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.

作者信息

Corrigan-Curay Jacqueline, Sacks Leonard, Woodcock Janet

机构信息

Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

出版信息

JAMA. 2018 Sep 4;320(9):867-868. doi: 10.1001/jama.2018.10136.

DOI:10.1001/jama.2018.10136
PMID:30105359
Abstract
摘要

相似文献

1
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.用于评估药物安全性和有效性的真实世界证据与真实世界数据。
JAMA. 2018 Sep 4;320(9):867-868. doi: 10.1001/jama.2018.10136.
2
[Not Available].[不可用]。
Recenti Prog Med. 2019 Nov;110(11):526-527. doi: 10.1701/3265.32349.
3
Real-world evidence-What is it and does it matter for approval of drugs?真实世界证据——它是什么以及它对药物批准重要吗?
J Am Acad Dermatol. 2018 Aug;79(2):390-391. doi: 10.1016/j.jaad.2018.01.040. Epub 2018 Feb 2.
4
Bill to boost medical research funding and speed drug approval passes US house.旨在增加医学研究资金并加快药物审批的法案在美国众议院获得通过。
BMJ. 2016 Dec 1;355:i6498. doi: 10.1136/bmj.i6498.
5
Real-World Evidence in the Real World: Beyond the FDA.现实世界中的真实世界证据:超越美国食品药品监督管理局
Am J Law Med. 2018 May;44(2-3):161-179. doi: 10.1177/0098858818789423.
6
Boulevard of broken dreams: drug approval for older adults with acute myeloid leukemia.破碎梦想之路:老年急性髓系白血病患者的药物批准
J Clin Oncol. 2012 Nov 20;30(33):4061-3. doi: 10.1200/JCO.2012.44.2962. Epub 2012 Sep 24.
7
Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval.假设:一项临床试验加上有效性的因果证据足以批准药物。
Clin Pharmacol Ther. 2003 Jun;73(6):481-90. doi: 10.1016/S0009-9236(03)00018-3.
8
Accelerated approval of oncology drugs: can we do better?肿瘤药物的加速批准:我们能否做得更好?
J Natl Cancer Inst. 2011 Apr 20;103(8):616-7. doi: 10.1093/jnci/djr104. Epub 2011 Mar 21.
9
Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.获得美国食品药品监督管理局加速批准的新型治疗药物的累积证据的时间和特征。
Milbank Q. 2017 Jun;95(2):261-290. doi: 10.1111/1468-0009.12261.
10
Real-world studies no substitute for RCTs in establishing efficacy.在确定疗效方面,真实世界研究无法替代随机对照试验。
Lancet. 2019 Jan 19;393(10168):210-211. doi: 10.1016/S0140-6736(18)32840-X.

引用本文的文献

1
LitAutoScreener: Development and Validation of an Automated Literature Screening Tool in Evidence-Based Medicine Driven by Large Language Models.LitAutoScreener:由大语言模型驱动的循证医学中自动化文献筛选工具的开发与验证
Health Data Sci. 2025 Sep 2;5:0322. doi: 10.34133/hds.0322. eCollection 2025.
2
Ethical and secure evidence generation from regionwide clinical data through a collaborative environment for advancing predictive care.通过协作环境从区域范围内的临床数据中生成符合伦理且安全的证据,以推进预测性医疗。
Front Public Health. 2025 Aug 8;13:1630351. doi: 10.3389/fpubh.2025.1630351. eCollection 2025.
3
Concordance Between Survey and Electronic Health Record Data in the COVID-19 Citizen Science Study: Retrospective Cohort Analysis.
COVID-19公民科学研究中调查数据与电子健康记录数据的一致性:回顾性队列分析
JMIR Form Res. 2025 Jul 28;9:e58097. doi: 10.2196/58097.
4
Transporting trial results to synthetic real-world populations in order to estimate real-world effectiveness of newly marketed medicines.将试验结果应用于合成的真实世界人群,以评估新上市药物的真实世界疗效。
BMJ Open. 2025 Jul 24;15(7):e089218. doi: 10.1136/bmjopen-2024-089218.
5
Negative control-calibrated difference-in-difference analyses: addressing unmeasured confounding in RWD with application to racial/ethnic differences.阴性对照校准的双重差分分析:解决真实世界数据中未测量的混杂因素并应用于种族/族裔差异研究
NPJ Digit Med. 2025 Jul 17;8(1):452. doi: 10.1038/s41746-025-01821-w.
6
Identification of medication-microbiome interactions that affect gut infection.鉴定影响肠道感染的药物-微生物组相互作用。
Nature. 2025 Jul 16. doi: 10.1038/s41586-025-09273-8.
7
Evaluating the agreement between sensitivity and primary analyses in observational studies using routinely collected healthcare data: a meta-epidemiology study.使用常规收集的医疗保健数据评估观察性研究中敏感性分析与主要分析之间的一致性:一项元流行病学研究。
BMC Med. 2025 Jul 1;23(1):393. doi: 10.1186/s12916-025-04199-4.
8
Qualitative evaluation by community health professionals of a technology design for recording and mobilizing patient reported care narratives.社区卫生专业人员对用于记录和调动患者报告的护理叙事的技术设计进行的定性评估。
Digit Health. 2025 Jun 25;11:20552076251350932. doi: 10.1177/20552076251350932. eCollection 2025 Jan-Dec.
9
Five-Year Delivery Rate and Time to Delivery Among Women With and Without Rheumatoid Arthritis: A Real-World Analysis Using a Nationwide Claims Database in Japan.患有和未患类风湿关节炎女性的五年分娩率及分娩时间:一项使用日本全国索赔数据库的真实世界分析。
Int J Rheum Dis. 2025 Jun;28(6):e70296. doi: 10.1111/1756-185X.70296.
10
Data-Driven Defragmentation: Achieving Value-Based Sarcoma and Rare Cancer Care Through Integrated Care Pathway Mapping.数据驱动的碎片整理:通过综合护理路径映射实现基于价值的肉瘤和罕见癌症护理
J Pers Med. 2025 May 19;15(5):203. doi: 10.3390/jpm15050203.