Compact versus contract--industry sponsors' obligations to their research subjects.
Compact versus contract--industry sponsors' obligations to their research subjects.
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紧凑与合同——行业赞助商对其研究课题的义务。
DOI：
10.1056/nejmhle067499
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发表时间：
2007
期刊：
影响因子：
--
通讯作者：
Joffe,Steven
中科院分区：
文献类型：
--
作者：
Mello,MichelleM;Joffe,Steven
Public unease about industry’s influence over clinical research has never been greater. Recent events have elevated concerns about financial ties among investigators, academic medical centers, and industry sponsors, 1-4 and disquieting findings have emerged about the legal relationships these entities form to conduct clinical trials. 5-8 Tort litigation brought by injured research subjects has accentuated the legal dimensions of clinical research relationships. 9-11 These areas of focus converged in Abney v. Amgen, an important case decided in March 2006 by the US Court of Appeals for the Sixth Circuit. 12 The dispute centered on the legal obligation of an industry sponsor to provide clinical-trial participants with an investigational medication after the termination of a study. The court held that despite a provision in the consent form stating that subjects could elect to continue taking the study drug for up to 2 years after the trial ended, the sponsor had no obligation to provide the drug. It grounded this conclusion in a determination that the plaintiffs had not entered into a legal relationship with the sponsor that would bind Amgen to fulfill this promise. The Abney case raises weighty legal issues for academic medical centers and their research faculty, as well as troublesome ethical questions. 13 The case underscores that notwithstanding the advantages of an arms-length relationship between academic investigators and industry sponsors, such an arrangement has undesirable legal consequences. the gdnf clinical trial
