中美药物临床试验中的药品管理现状比较

目的:为完善我国药物临床试验中的药品管理提出建议。方法:以"药物临床试验质量管理规范""临床试验药物""临床试验用药品""GCP""Investigational drug products"等为关键词,组合查询中国知网、万方数据、PubMed、OVID等数据库2014年7月-2018年7月收录的相关文献,对中美药物临床试验中的药品管理指南、管理体系(包括管理模式、人员配置、预算评估)的差异进行归纳总结,并对我国临床试验用药品管理过程中的不足提出建议。结果与结论:共检索到相关文献154篇,其中有效文献33篇。美国临床试验用药品管理指南较为完善,比如有美国医院药师学会颁布的《临床试验药品管理指南》,而我国尚未出台此类全国性指南。美国临床试验用药品管理包括医院药事部门药师兼职管理和多名专职药师与药学技术员管理2种模式,由药师或药学技术人员参与管理的全流程,且对临床试验用药品管理预算评估开展了较多研究;我国临床试验用药品管理包括专职药师管理、专职药师与兼职护士管理、兼职药师与兼职护士管理3种模式,由药师和护士共同参与管理但尚未做到全流程管理,且对临床试验用药品管理预算评估研究较少。建议我国临床试验用药品管理可通过细化临床试验用药品管理制度、规范临床试验用药品管理模式以及开展管理预算评估等方式,提高临床试验用药品的管理效率和水平,促进我国药物临床试验管理质量的提升。

Comparison of Current Status of Drug Management in Clinical Trials between China and the United States

OBJECTIVE:To put forward the suggestions for improving drug management in clinical drug trials in China.METHODS:“Good clinical practice”“Clinical trials drug”“Drugs for clinical trials”“GCP”“Investigational drug products”as search terms,searching CNKI database,Wanfang database,PubMed database and OVID electronic journal full-text database during Jul.2014-Jul.2018.The differences of drug management guidelines and management systems(including management model,staffing and budget evaluation)in clinical drugs between China and the United States were summarized.The suggestions were put forward to the shortage of drugs management of clinical trials in China.RESULTS&CONCLUSIONS:A total of 154 literatures were retrieved,including 33 valid literatures.The guidelines for drug management in clinical trials in the United States were relatively perfect,such as the Guidelines for Drug Management in Clinical Trials promulgated by the American Society of Hospital Pharmacists,while China had not yet published such national guidelines.The drug management in clinical trials in the United States had two modes which is the management of part-time pharmacists in hospital pharmacy department and the management of several full-time pharmacists and pharmacy technicians.Pharmacists or pharmaceutical technicians participated in the whole process of management,and a lot of research was carried out on the budget evaluation of clinical trials drug management.Domestic clinical trials drug management included three modes which is full-time pharmacist management,full-time pharmacist and part-time nurse management,part-time pharmacist and part-time nurse management.Pharmacists and nurses jointly participated in the management,but the whole process management had not yet been achieved,and there were few studies on budget evaluation of clinical trials drug management.It is suggested that the management of clinical trials drug in China can improve the management efficiency and level of clinical trials drug by refining the management system of clinical trials drug,standardizing the management mode of clinical trials drug and carrying out management budget evaluation.