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私营部门的研究伦理:市场营销还是良好的冲突管理?2005年约翰·J·康利医学伦理讲座

Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

作者信息

Dresser Rebecca

机构信息

School of Law, Program in Medicine and the Humanities, Washington University, One Brookings Drive, Box 1120, St. Louis, MO 63130, USA.

出版信息

Theor Med Bioeth. 2006;27(2):115-39. doi: 10.1007/s11017-005-5289-5.

DOI:10.1007/s11017-005-5289-5
PMID:16699963
Abstract

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

摘要

制药公司是生物医学研究的主要赞助商。然而,大多数学者和政策制定者将注意力集中在政府和学术监督活动上。在本文中,我探讨了制药公司内部道德声明在指导企业研发决策方面的作用。我回顾了制药公司网站上的资料以及商业和医学伦理文献中关于企业,特别是制药公司道德责任的论述。我讨论了制药公司道德材料的积极和消极用途,并描述了公司现有道德计划中的不足之处。为了指导员工并安抚外部人士,公司必须在其研发道德计划中增加严谨性、独立性和透明度。

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Bone regeneration: stem cell therapies and clinical studies in orthopaedics and traumatology.骨再生:矫形和创伤学中的干细胞疗法和临床研究。
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本文引用的文献

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A new era in drug regulation?药品监管的新时代?
Hastings Cent Rep. 2005 May-Jun;35(3):10-1.
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Tailoring arthritis therapy in the wake of the NSAID crisis.在非甾体抗炎药危机后调整关节炎治疗方案。
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Academic medical centers' standards for clinical-trial agreements with industry.学术医疗中心与行业签订临床试验协议的标准。
N Engl J Med. 2005 May 26;352(21):2202-10. doi: 10.1056/NEJMsa044115.
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Gag clauses in clinical-trial agreements.临床试验协议中的保密条款。
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Institutional conflicts of interest: protecting human subjects, scientific integrity, and institutional accountability.
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Clinical trials. Facing criticism, industry offers to share data.临床试验。面对批评,行业提出共享数据。
Science. 2005 Jan 14;307(5707):189. doi: 10.1126/science.307.5707.189b.
8
Potential for conflict of interest in the evaluation of suspected adverse drug reactions: a counterpoint.评估疑似药物不良反应时利益冲突的可能性:一种反对观点
JAMA. 2004 Dec 1;292(21):2643-6. doi: 10.1001/jama.292.21.2643. Epub 2004 Nov 22.
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Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis.评估疑似药物不良反应时利益冲突的可能性:西立伐他汀的使用与横纹肌溶解风险
JAMA. 2004 Dec 1;292(21):2622-31. doi: 10.1001/jama.292.21.2622. Epub 2004 Nov 22.
10
Clinical trial registration: a statement from the International Committee of Medical Journal Editors.临床试验注册:国际医学期刊编辑委员会声明
N Engl J Med. 2004 Sep 16;351(12):1250-1. doi: 10.1056/NEJMe048225. Epub 2004 Sep 8.