Abadie E
Syndicat National de l'Industrie Pharmaceutique, Paris.
Encephale. 1990 Jul-Aug;16(4):275-6.
Clinical research is indispensable for determining the safety and efficacy of drugs in human. It provides the scientific basis for rational drug usage. Methodology of clinical trials can raise some ethical issues. As an example the use of a placebo is described in this paper. Generally the ethical issues may be solved by the adequate information of every individual assigned to clinical investigation in agreement with the Declaration of Helsinki and the Huriet law. This information must be approved by an ethical committee. Finally an information about the general provisions of clinical trials must be destined to the general public.
临床研究对于确定药物在人体中的安全性和有效性不可或缺。它为合理用药提供科学依据。临床试验方法可能引发一些伦理问题。本文以安慰剂的使用为例进行了描述。一般来说,伦理问题可通过按照《赫尔辛基宣言》和《胡里埃法》,向参与临床研究的每一个体提供充分信息来解决。此信息必须经伦理委员会批准。最后,关于临床试验一般规定的信息必须面向公众发布。