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药物研发试验中治疗分配的伦理考量

Ethical considerations concerning treatment allocation in drug development trials.

作者信息

Senn S

机构信息

Department of Epidemiology and Public Health, Department of Statistical Science, University College London, Gower Street, London WC1E 6BT, UK.

出版信息

Stat Methods Med Res. 2002 Oct;11(5):403-11. doi: 10.1191/0962280202sm299ra.

DOI:10.1191/0962280202sm299ra
PMID:12357586
Abstract

It is claimed that much of the opposition to placebos is based on the misunderstanding that their use implies the withholding of effective treatments. It is also argued that the ethical feasibility of a trial must be judged by comparing the likely prognosis of patients in the trial to their expectations outside the trial. Furthermore, a longer-term perspective of the patients needs is necessary; the ethical dilemmas involved cannot be resolved at the point of sickness. Some device such as the 'original position' of the philosopher John Rawls is needed. Finally, it is argued that placebo run-ins involve a violation of consent and should be eliminated from clinical trials.

摘要

有人认为,对安慰剂的许多反对意见是基于一种误解,即使用安慰剂意味着不提供有效的治疗方法。还有人认为,试验的伦理可行性必须通过比较试验中患者的可能预后与他们在试验外的预期来判断。此外,需要从患者需求的更长期角度来看待;所涉及的伦理困境在患病时无法解决。需要一些诸如哲学家约翰·罗尔斯的“原初状态”之类的设想。最后,有人认为安慰剂导入期涉及违反知情同意原则,应该从临床试验中消除。

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