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Real-world evidence and regulatory drug approval.

作者信息

Raphael Michael J, Gyawali Bishal, Booth Christopher M

机构信息

Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, Canada.

Department of Oncology, Queen's University, Kingston, Canada.

出版信息

Nat Rev Clin Oncol. 2020 May;17(5):271-272. doi: 10.1038/s41571-020-0345-7.

DOI:10.1038/s41571-020-0345-7
PMID:32112057
Abstract
摘要

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Clin Cancer Res. 2020 Mar 15;26(6):1208-1212. doi: 10.1158/1078-0432.CCR-19-2580. Epub 2019 Oct 24.
图西诺司他治疗晚期激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者的疗效与安全性：真实世界的见解
Ann Transl Med. 2023 Dec 20;11(12):409. doi: 10.21037/atm-23-1913. Epub 2023 Dec 19.
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Commercializing Personal Health Information: A Critical Qualitative Content Analysis of Documents Describing Proprietary Primary Care Databases in Canada.将个人健康信息商业化：对加拿大描述专有的初级保健数据库的文件进行批判性定性内容分析。
Int J Health Policy Manag. 2023;12:6938. doi: 10.34172/ijhpm.2023.6938. Epub 2023 May 2.
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Evaluation of reporting quality of cohort studies using real-world data based on RECORD: systematic review.基于 RECORD 评价真实世界数据队列研究报告质量：系统评价。
BMC Med Res Methodol. 2023 Jun 29;23(1):152. doi: 10.1186/s12874-023-01960-2.
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Outcomes of Chemoimmunotherapy Among Patients With Extensive-Stage Small Cell Lung Cancer According to Potential Clinical Trial Eligibility.广泛期小细胞肺癌患者根据潜在临床试验资格的化疗免疫治疗结果。
JAMA Netw Open. 2023 Feb 1;6(2):e230698. doi: 10.1001/jamanetworkopen.2023.0698.
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Fast Methods for Drug Approval: Research Perspectives for Pandemic Preparedness.快速药物审批方法：大流行防范的研究视角。
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Advancing Pharmacogenomics from Single-Gene to Preemptive Testing.推进单基因检测向药物基因组学预测性检测的发展。
Annu Rev Genomics Hum Genet. 2022 Aug 31;23:449-473. doi: 10.1146/annurev-genom-111621-102737. Epub 2022 May 10.
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Cancer treatments should benefit patients: a common-sense revolution in oncology.癌症治疗应使患者受益：肿瘤学的一场常识性变革。
Nat Med. 2022 Apr;28(4):617-620. doi: 10.1038/s41591-021-01662-6.
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Correlation Between Early Endpoints and Overall Survival in Non-Small-Cell Lung Cancer: A Trial-Level Meta-Analysis.非小细胞肺癌早期终点与总生存期的相关性：一项试验水平的荟萃分析
Front Oncol. 2021 Jul 26;11:672916. doi: 10.3389/fonc.2021.672916. eCollection 2021.