药物临床试验质量控制中发现的问题及改进措施

Drug clinical trial institution node problems and countermeasures in quality control

目的通过收集药物临床试验项目结题质控中发现的问题,分析原因,提出对策,从而提高药物临床试验的质量。方法采用回顾性分析方法,对某院2012年结题项目质量控制中发现的问题进行归类分析。结果审核的项目中,出现的主要问题依次有:试验记录不规范(占75.00%),如填写和更改病例报告表(CRF)、临床试验相关记录不规范(占54.16%);不良事件(AE)记录不完整(占9.80%)、严重不良事件(SAE)记录不完整(占2.44%);试验用药品管理不规范(占2.44%),如试验用药品的使用、回收或销毁记录不完整;实验室检查不完整(占6.25%)等。结论产生上述问题的原因主要有研究者培训不合格、未能严格遵循试验方案及相关法规、对部分试验环节不够重视等,因此提出相应的对策,使临床试验的实施更加规范,有助于提高药物临床试验的水平。

Objective To analyze the causes of problem which were found in the drug clinical trial by the project quality control,and put forward countermeasures,so as to improve the quality of drug clinical trials.Methods Retrospective analysis method was used to classify the problems that were found in the quality control in 2012 at a certain hospital.Results The main problems of audit project were：the test records were not standardized（75 ％）,such as fill in and change the case report form（CRF） ;the relevant records of clinical trials was not standardized（54.16％） ;adverse events （AE） record （9.80 ％） and serious adverse events （SAE） record （2.44 ％） were in complete; test drug management was incorrect（2.44％）,including the records of experimental drug use,recycling or destruction of records were incomplete ;laboratory examination was in complete （6.25 ％）.Conclusion These problems are mainly due to unqualified training,protocols and relevant laws deviation,inadequate attention to the trail,and so on.Thus,to resolve these problems,we should put forward the corresponding countermeasure and standardize the implementation of clinical trials to improve the level of drug clinical trials.