药物临床试验中科学原则、法规原则与伦理原则的权重与取舍

Weights and Choices of Scientific,Legislation and Ethical Principles in Clinical Drug Trials

药物临床试验既要符合伦理学原则、法规原则,又要具备科学原则。伦理学原则要求受试者最大程度受益和尽可能避免伤害。在法规原则上也首先强调的是受试者的权益,然而试验设计的科学性原则有很多时候却对伦理学提出了挑战。当药物临床试验的科学性、法规性与伦理性发生矛盾时,我们应把伦理问题摆在首位。

The clinical drug trails should accord to ethics, legislation and scientific principles. The ethical principle requires that the rights and benefits of the subjects be maximized while risks should be minimized. Regulations also put first empha- sis On the subjects＇ beneficial interest. However, experimental designs based on scientific principle often present challen- ges to ethical principle. When the legislation and scientific principles are contrary to ethical princip/e in the clinical drug trails, priority must be given to ethics.