摘要
目的:通过研究危害分析和关键控制点(HACCP)方法,结合疫苗临床试验现场步骤或环节风险评估实例,从实际应用角度出发,提出基于风险制定疫苗临床监查策略的意见建议。方法:运用文献分析方法、案例分析法,分析和借鉴成功的经验。结果与结论:我国的疫苗研制单位应根据具体临床试验特点和法规要求,对临床现场各步骤或环节进行风险评估,根据评估结果合理制定并实施监查策略,达到保证临床试验科学规范、真实可靠的目的。此外,也可将此方法应用到所有药品临床试验领域,有效确保临床试验质量。
Objective: From the perspective of practical application,through the research of HACCP method,and combined with the example of risk assessment to steps or departments in on-site vaccine clinical trial,give suggestion and advice to establish the strategy of Risk-based monitoring in vaccine clinical trial. Methods: Using the method of literature research and Combined with the instance,analyzes and draws lessons from the successful experience. Results and Conclusion: According to the characteristics and regulations of clinical trials,Chinese vaccine development company should assess risk of each step or department in on-site clinical trials. According to the evaluation results,reasonably establish and implement monitoring strategies so as to ensure scientificalness,normalization,reality and reliability of clinical trial. In addition,this method of the paper can also be applied to all drug clinical trials to effectively ensure the quality of clinical trials.
作者
王翔
WANG Xiang(Beijing Minhai Biotechnology Co.,Ltd.Beijing New Combined Vaccine Engineering Technology Research Center,Beijing 102600,China)
出处
《中国药物评价》
2019年第6期464-469,共6页
Chinese Journal of Drug Evaluation
