临床试验用药品管理存在的问题及对策分析

Analysis and Countermeasures of the Problems in the Management of Investigational Products in Clinical Trials

目的探讨临床试验机构试验用药品管理问题及策略,以保障受试者的用药安全。方法对我院药物临床试验机构2018年1月至2019年12月在研的21项药物临床试验的试验用药品的接收、储存、分发、使用、回收、返还记录的质控报告进行汇总分析,对存在的问题提出解决对策和建议。结果试验用药品管理不合格项19项,共计152个。其中,试验用药品接收环节问题26个(占17.11%),储存环节问题60个(占39.47%),分发环节问题20个(占13.16%),使用环节问题18个(占11.84%),回收环节问题23个(占15.13%),返还环节问题5个(占3.29%)。结论药物临床试验机构应加强试验用药品管理质控及试验用药品管理的培训,通过建立GCP中心药房,配备专职试验用药品管理员,构建试验用药品管理信息化系统,从而提高试验用药品管理水平,保证药物临床试验质量。

Objective To discuss the management problems and strategies of trial drugs in clinical trial institutions to ensure the safety of subjects'medication.Methods From January 2018 to December 2019,the quality control reports of the receiving,storage,distribution,use,recovery and return records of 21 clinical trials in our hospital were summarized and analyzed.And the countermeasures and suggestions on how to solve the existing problems were made.Results A total of 152 cases were found in 19 unqualifi ed items of the management of investigational products.Among them,there were 26 cases in receiving problems(17.11%),60 cases(39.47%)in storage,20 cases(13.16%)in distribution,18 cases(11.84%)in use,23 cases(15.13%)in recovery and 5 cases(3.29%)in return.Conclusion The training of process quality control and management of investigational products should be strengthened in the institutions.The GCP central pharmacy should be established.It is necessary to have full-time staff s responsible for the management of investigational products,and the information system of management of investigational products should bebuilt.The above measures will help to improve the management level of investigational products and ensure the quality of clinical trials.