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Pragmatic Clinical Trials: The Ethics of Conducting Research in the Real World.

作者信息

Vaszar Laszlo T, Sharp Richard R, Carter Rickey E, Wright R Scott

机构信息

Institutional Review Board, Department of Medicine, Division of Pulmonary Medicine, Mayo Clinic Arizona, Phoenix, AZ, USA.

Department of Quantitative Health Sciences, Biomedical Ethics Research Program, Mayo Clinic Rochester, Rochester MN, USA.

出版信息

Mayo Clin Proc. 2024 Sep;99(9):1369-1373. doi: 10.1016/j.mayocp.2024.05.001. Epub 2024 Aug 5.

DOI:10.1016/j.mayocp.2024.05.001
PMID:39101864
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11831573/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6c5/11831573/45d89d01a56f/nihms-2015079-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6c5/11831573/98563c87a672/nihms-2015079-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6c5/11831573/45d89d01a56f/nihms-2015079-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6c5/11831573/98563c87a672/nihms-2015079-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6c5/11831573/45d89d01a56f/nihms-2015079-f0002.jpg

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本文引用的文献

1
Compulsory Research in Learning Health Care: Against a Minimal Risk Limit.强制研究学习型医疗保健:反对最小风险限制。
Hastings Cent Rep. 2022 May;52(3):18-29. doi: 10.1002/hast.1392.
2
Learning Health Care and the Obligation to Participate in Research.学习型医疗保健与参与研究的义务。
Hastings Cent Rep. 2022 May;52(3):29-31. doi: 10.1002/hast.1393.
3
Public Attitudes toward Consent When Research Is Integrated into Care-Any "Ought" from All the "Is"?公众对将研究纳入医疗服务时的同意态度——所有“是”中是否存在任何“应当”?
Hastings Cent Rep. 2021 Mar;51(2):22-32. doi: 10.1002/hast.1242.
4
Trial designs using real-world data: The changing landscape of the regulatory approval process.使用真实世界数据的试验设计:监管审批流程的不断变化态势。
Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1201-1212. doi: 10.1002/pds.4932. Epub 2019 Dec 10.
5
Understanding preferences regarding consent for pragmatic trials in acute care.了解急性护理中实用临床试验同意书的偏好。
Clin Trials. 2018 Dec;15(6):567-578. doi: 10.1177/1740774518801007. Epub 2018 Oct 3.
6
Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol.制定医疗保健中实用临床试验的伦理设计和实施框架:混合方法研究方案。
Trials. 2018 Sep 27;19(1):525. doi: 10.1186/s13063-018-2895-x.
7
Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.实用随机对照试验中的伦理问题:对近期文献的综述揭示了伦理论证方面的差距。
BMC Med Ethics. 2018 Feb 27;19(1):14. doi: 10.1186/s12910-018-0253-x.
8
Reframing Consent for Clinical Research: A Function-Based Approach.重新构建临床研究中的同意书:基于功能的方法。
Am J Bioeth. 2017 Dec;17(12):3-11. doi: 10.1080/15265161.2017.1388448.
9
Ethics of Informed Consent for Pragmatic Trials with New Interventions.新型干预措施实用性试验的知情同意伦理问题
Value Health. 2017 Jul-Aug;20(7):902-908. doi: 10.1016/j.jval.2017.04.005. Epub 2017 May 16.
10
Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design.患者对急性心肌梗死临床试验中知情同意的看法:试验设计的影响。
J Med Ethics. 2017 Aug;43(8):524-529. doi: 10.1136/medethics-2016-103866. Epub 2016 Dec 30.