The two-faced angel: do phase I clinical trials have a place in modern hospice?

Penn bioethics journal Pub Date : 2006-01-01
Daniel S Ross
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Abstract

Increasingly, bioethicists have been exploring the possibility of making phase I clinical trials available to hospice patients. Phase I clinical trials are designed to test a drug's safety and dosage, not its effectiveness. Participants in these studies generally do not understand that the purpose of the investigation is not to benefit them, thus challenging the notion of informed consent. But furthermore, the idea that patients believe experimental drugs will help them is contrary to the principles of hospice. Also, the very nature of the research in phase I conflicts with hospice's methods. For these reasons, this paper finds that the two models must remain distinct.

双面天使:I期临床试验在现代临终关怀中有一席之地吗?
越来越多的生物伦理学家一直在探索将I期临床试验提供给临终关怀病人的可能性。第一阶段临床试验旨在测试药物的安全性和剂量,而不是其有效性。这些研究的参与者通常不明白调查的目的不是为了让他们受益,因此对知情同意的概念提出了挑战。而且,病人相信实验性药物会帮助他们的想法与临终关怀的原则相违背。此外,第一阶段研究的本质与安宁疗护的方法相冲突。基于这些原因,本文认为这两种模式必须保持不同。
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