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医疗机构对药物临床试验组织的不信任。

Institutional mistrust in the organization of pharmaceutical clinical trials.

作者信息

Fisher Jill A

机构信息

Center for Biomedical Ethics & Society, Vanderbilt University, 2525 West End Ave., Suite 400, Nashville, TN, 37203, USA.

出版信息

Med Health Care Philos. 2008 Dec;11(4):403-13. doi: 10.1007/s11019-008-9154-y. Epub 2008 Jul 17.

Abstract

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products.

摘要

在本文中,我探讨了美国药品临床试验中信任的政治学。具体而言,我从制药临床试验行业中信任的制度表现方面进行分析。在新药测试过程中,制药公司必须(1)保护其专有信息不被进行研究的临床医生获取,以及(2)找到一种方法来确保人类受试者遵守研究方案。对这两个关键问题的关注导致制药公司以不信任的态度接触临床医生和研究受试者,并希望对他们的活动施加控制。这种倾向导致了不信任的制度化,它构建了新药品临床开发所需的关系和活动。

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