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[从使用研究的设计到效益评估:有无制药行业参与?]

[From the design of use study to the assessment of the benefit: with or without pharmaceutical industry?].

作者信息

Porzsolt Franz

机构信息

Klinische Ökonomik, Universität Ulm, Ulm, Germany.

出版信息

Med Klin (Munich). 2010 Dec;105(12):930-5. doi: 10.1007/s00063-010-1159-7. Epub 2011 Jan 16.

DOI:10.1007/s00063-010-1159-7
PMID:21240593
Abstract

The financing of clinical studies by the pharmaceutical industry is a controversial topic both internationally and in here in Germany. The well-known unacceptable shortcomings require no further confirmation. It is, however, indisputable that the pharmaceutical industry and medical science are co-dependent. Neither the marketing of industrial products nor the research and education of clinical scientists could function without this cooperation. Therefore, all partners need suggestions concerning goal orientation and consensus. The aim of this discussion is to formulate just such suggestions. To structure this discussion, we have raised the following questions: Must we always be suspicious of the results of studies financed by the pharmaceutical industry? We have to keep in mind that in Germany all clinical trials leading to approval of a drug were supported by the industry. What, exactly, do we want to achieve with our explicit and often justified criticism of these studies? What should be done to achieve a higher validity of the published data if we avoid answering the decisive question of whether we accept the challenge of continuing to let research and teaching be financed by the pharmaceutical industry or reject this kind of cooperation and support altogether.

摘要

制药行业对临床研究的资助在国际上以及德国国内都是一个颇具争议的话题。那些广为人知的不可接受的缺陷无需进一步证实。然而,制药行业与医学科学相互依存这一点是无可争议的。没有这种合作,工业产品的营销以及临床科学家的研究与教育都无法开展。因此,所有合作伙伴都需要关于目标导向和共识的建议。本次讨论的目的正是提出这样的建议。为了构建本次讨论,我们提出了以下问题:我们是否必须始终对制药行业资助的研究结果持怀疑态度?我们必须牢记,在德国,所有导致药物获批的临床试验都得到了该行业的支持。对于这些研究,我们明确且往往合理的批评究竟想要达成什么目的?如果我们回避是否接受继续让制药行业资助研究与教学这一决定性问题,或者完全拒绝这种合作与支持,那么为了提高已发表数据的有效性,应该采取什么措施?

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Med Klin (Munich). 2010 May;105(5):345-50. doi: 10.1007/s00063-010-1063-1. Epub 2010 May 26.
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The financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication.制药公司资助药物试验及其后果:第 2 部分:对可能影响作者身份、试验数据获取以及试验注册和发表的文献进行定性、系统的综述。
Dtsch Arztebl Int. 2010 Apr;107(17):295-301. doi: 10.3238/arztebl.2010.0295. Epub 2010 Apr 30.
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The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials.制药公司资助药物试验及其后果。第 1 部分:对可能影响药物试验结果、方案和质量的文献进行定性、系统的回顾。
Dtsch Arztebl Int. 2010 Apr;107(16):279-85. doi: 10.3238/arztebl.2010.0279. Epub 2010 Apr 23.
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Drug research: marketing before evidence, sales before safety.药物研究:证据未出便进行营销,安全未证便开始销售。
Dtsch Arztebl Int. 2010 Apr;107(16):277-8. doi: 10.3238/arztebl.2010.0277. Epub 2010 Apr 23.
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