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临床试验的科学性和伦理问题 被引量:5

Scientific and Ethical Issues in Clinical Trials
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摘要 提出了临床试验中7种不符合伦理的情况,并以实例说明。同时介绍了符合伦理的临床试验的一种新的设计方法——动态设计以及实施动态设计所需要建立的独立数据检查委员会。最后讨论了动态设计的中文译名。 Seven types of unethical and their examples and a new and ethical design -- the adaptive design were introduced. The Independent Data Monitoring Committee, which is necessary for adaptive design,was also introduced. At the end of this paper,the Chinese translations of names o~ adaptive design were discussed.
作者 金丕焕
出处 《医学与哲学(A)》 北大核心 2010年第3期8-10,共3页 Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词 伦理 临床试验 动态设计 ethics, clinical trial, dynamic design
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参考文献3

  • 1World Medical Association. Declaration of Helsinki[S]. 59^th WMA General Assembly of World Medical Association,Seoul,2008.
  • 2International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Topic E6 Guide line for Good Clinical Practice[S/OL]. [2010 -02- 02]. http://www, ema. europa, eu/pdfs/human/ich/013595en, pdf.
  • 3Moher D, Schulz K F,Altman D G,et al. The CONSORT statement re vised recommendation for improving the quality of reports of Parallel- group randomised trials[J]. Lancet, 2001,357 : 1191 - 1194.

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