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医疗器械企业家的利益冲突应对之道。

Navigating conflicts of interest for the medical device entrepreneur.

机构信息

Ethics Institute, Dartmouth College (AD) and Cardiology Section Dartmouth Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth (AVK), Lebanon, NH 03756-0001, USA.

出版信息

Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):316-20. doi: 10.1016/j.pcad.2012.10.008.

DOI:10.1016/j.pcad.2012.10.008
PMID:23217436
Abstract

The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies.

摘要

在过去的五十年中,心血管疾病患者的理解和治疗取得了显著进展,为症状缓解和寿命显著延长带来了希望。这些进展在很大程度上要归功于新技术的开发、研究和应用。特别是在介入心脏病学领域,这些进展是由医疗器械形式的新技术的可用性所驱动的。成功的设备开发工作需要基础科学家、临床医生发明家/企业家、临床医生研究者和公司之间的密切合作。尽管临床医生的角色是这一过程的核心,但这些活动带来了重要的利益冲突(COIs)。本文的目的是:1)描述这些冲突,2)提供一个管理这些冲突的背景,3)推荐管理策略。

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引用本文的文献

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Defining the clinician's role in early health technology assessment during medical device innovation - a systematic review.定义医疗器械创新早期卫生技术评估中临床医生的角色 - 系统评价。
BMC Health Serv Res. 2019 Jul 23;19(1):514. doi: 10.1186/s12913-019-4305-9.
2
Innovation for the future of Irish MedTech industry: retrospective qualitative review of impact of BioInnovate Ireland's clinical fellows.爱尔兰医疗技术行业未来的创新:对爱尔兰生物创新临床研究员影响的回顾性定性研究
BMJ Innov. 2018 Jan;4(1):32-38. doi: 10.1136/bmjinnov-2016-000184. Epub 2017 Nov 24.
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Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study.
美国制药和医疗器械制造商向美国医学期刊编辑的付款情况:回顾性观察研究。
BMJ. 2017 Oct 26;359:j4619. doi: 10.1136/bmj.j4619.
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"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.“我们彼此离不开”:针对医生就器械行业代表、利益冲突和患者安全问题进行的定性访谈
PLoS One. 2017 Mar 30;12(3):e0174934. doi: 10.1371/journal.pone.0174934. eCollection 2017.