专职药师在临床试验用药品管理中的重要作用

The important role of full-time pharmacists in drug administration of clinical trials

现阶段我国临床试验用药品的管理尽管发展空前迅速,但尚无一特定的模式,各家对试验用药品管理模式的理解和操作存在差异。本文拟通过对国内外药物临床试验用药品管理现状的介绍与分析,结合我国临床试验用药品管理的发展历程,从中汲取国内外临床试验药品管理经验,为今后我国临床试验用药品的管理发展提出建议。提高我国规范临床试验用药品管理,提高临床试验质量管理,确保临床试验过程真实规范、结果科学可靠。

At present,the management of drugs used in clinical trials is developing rapidly in China,but there is still no specific model. There are differences in the understanding and operation of the experimental drug management mode among different institutions. This article intends to introduce and analyze the domestic and foreign status of management of drugs used in clinical trials,combined with the development of medicine management of clinical trials in China,to absorb experiences in this field and propose recommendations for the future drug management of clinical trials in China. The objective is to standardize the clinical trials in China,improve the quality control of clinical trials,and ensure the authenticity of the results of clinical trials.