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[临床研究人员与制药行业。研究合同并非附录]

[Clinical researchers and the pharmaceutic industry. The research contract is not an addendum].

作者信息

Cohen A F

机构信息

Afd. Klinische Farmacologie, Universiteit Leiden.

出版信息

Ned Tijdschr Geneeskd. 1999 Jun 26;143(26):1345-9.

PMID:10416489
Abstract

The relation between a pharmaceutical company and a clinical investigator combines a certain form of entrepreneurship with scientific endeavour. Both parties are concerned with the content of the clinical study as well as with its business aspects. A good contract is essential for the project to succeed. In three cases based on actual experience the contract failed. In the first case, dosage miscalculation in the hospital pharmacy led to side effects in patients as a consequence of which the study was stopped. The pharmaceutical company sued the investigator. In the second case the investigator published data in a congress abstract, which prevented a patent by the company. In the third case scientific information was published by the company with the principal investigator featuring in the acknowledgement section of the article only. Investigators should have their own standard contract ready, and they should invest time and energy in understanding the contracts of the research they are carrying out.

摘要

制药公司与临床研究人员之间的关系将某种形式的创业精神与科学努力结合在了一起。双方既关注临床研究的内容,也关注其商业方面。一份好的合同对于项目的成功至关重要。基于实际经验的三个案例中,合同均告失败。在第一个案例中,医院药房的剂量计算错误导致患者出现副作用,结果研究被迫停止。制药公司起诉了研究人员。在第二个案例中,研究人员在会议摘要中发表了数据,这使得公司无法获得专利。在第三个案例中,公司发表了科学信息,而文章致谢部分仅提及了主要研究人员。研究人员应该准备好自己的标准合同,并且应该投入时间和精力去理解他们正在进行的研究的合同。

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