Lexchin Joel
School of Health Policy and Management, York University, 4700 Keele St., Toronto, Ontario M3J 1P3, Canada.
J Pharm Policy Pract. 2013 Dec 2;6:11. doi: 10.1186/2052-3211-6-11. eCollection 2013.
Clinical trials present an ethical dilemma for pharmaceutical companies. While companies may want to undertake and report these trials in an ethical manner, negative results can significantly affect product sales. There is accumulating evidence that company-financed trials are biased in favor of the product that the company makes. Ethical conduct in this article is defined as whether the trials are conducted in the best interests of the participants and/or reported in the best interests of patients. Nine examples of how clinical trials are violating multiple articles in the Declaration of Helsinki are discussed using concrete case reports from the literature. The recognition of ethical problems in company run trials is not something new, but to date no meaningful action has been taken to resolve this issue. What is necessary is to separate the financing of clinical trials from their conduct.
临床试验给制药公司带来了伦理困境。虽然公司可能希望以符合伦理的方式开展和报告这些试验,但负面结果会显著影响产品销售。越来越多的证据表明,公司资助的试验存在偏向公司所生产产品的倾向。本文中的道德行为定义为试验是否以参与者的最大利益进行以及/或者报告是否符合患者的最大利益。本文使用文献中的具体案例报告,讨论了临床试验违反《赫尔辛基宣言》多篇条款的九个例子。对公司开展的试验中伦理问题的认识并非新鲜事,但迄今为止尚未采取有意义的行动来解决这一问题。有必要将临床试验的资金来源与试验实施分开。