药物临床试验设计的伦理思考

Ethical Considerations about Clinical Trial Designs of Drugs

目前广泛采用的药物临床试验设计中,由于不能使受试者最大限度的受益而在伦理学方面存在弊端。自适应设计方法的出现,为克服这一弊端提供了现实途径,可使药物临床试验的受试者能够最大程度的受益。本文从传统临床试验引发的伦理问题入手,阐述了自适应设计以人为本的特点,探讨了其在解决伦理与疗效冲突问题中的重要作用。

The widely--used clinical trial designs of drugs currently is facing new challenges because it can＇t satisfy an ethi cal imperative of caring for the individual patient due to not making maximum benefit for him. The emergence of adaptive design methodology provides a realistic way to overcome this shortcoming and is able to make the greatest degree of benefit for the individual patient. Starting with the ethical problems triggered from a traditional clinical trial,this paper depicts the human--oriented features of the adaptive design and discusses its important effects in resolving the conflict between ethics and drug efficacy.