药师在药物临床试验中的机遇与挑战

The opportunity and challenge for pharmacists in drug clinical trials

由于临床试验全球化发展使得国际多中心药物临床试验项目日益增加且试验设计更为严谨、复杂。药师具备扎实的药物治疗学、临床药理学、药动学等系统的药学专业知识,对药物信息的掌握较为全面,不论对研发过程还是临床治疗均有所涉及,因此其在临床试验过程中占有举足轻重的地位。具备药学知识且熟悉临床试验相关政策法规的药师参与临床试验团队合作中,将有助于提升临床试验执行的水平与质量。本文将结合实施药物临床试验的前、中、后3个阶段对药师的作用进行分析,探讨药师在药物临床试验管理中的机遇与挑战。

The globalization of clinical trials leads to an increasing number of international multi-center drug clinical trials and requires the trials to be designed more rigorous and complicated. Compared with clinical physicians, pharmacists hold specific characteristics in terms of comprehensive knowledge of drug usage, systemic framework of clinical pharmacology, pharmacokinetics, as well as deep understanding of clinical trial regulations. For these characteristics, pharmacists could play a pivotal role during the clinical trials implementation. The partic- ipation of pharmacists who have pharmaceutical knowledge and are familiar with the policies and regulations of clinical trials can help ensure the quality and execution of clinical trials. This paper aims to analyze the role of pharmacists before, during, and after the clinical trials. Besides that, this paper would also discuss the opportunity and challenge for pharmacists in the regulation of drug clinical trials.