药物临床试验机构备案制对药物Ⅰ期临床试验质量影响的风险管理研究
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摘要
目的:通过药物临床试验机构备案制管理对药物Ⅰ期临床试验影响的风险指标进行识别和评估,为控制药物Ⅰ期临床试验质量风险提出建议。方法:运用风险管理理论、文献研究法和专家访谈法,识别影响药物Ⅰ期临床试验质量的风险指标,并通过专家问卷调查和层次分析法对风险指标的重要性进行评估,得出各风险指标的权重,据此提出建议。结果:在药物临床试验机构备案制下,药物临床试验沟通交流和药物Ⅰ期临床试验机构自身建设是影响药物Ⅰ期临床试验的重要环节;药物临床试验审评审批以及申办方或第三方评估药物Ⅰ期临床试验机构也对临床试验质量具有一定影响。结论:应控制好影响药物临床试验沟通交流、药物Ⅰ期临床试验机构自身建设、药物临床试验审评审批和申办方或第三方评估药物Ⅰ期临床试验机构的相关风险要素,提升药物Ⅰ期临床试验质量。
Objective: Identify and evaluate risk indicators for the impact of phase Ⅰ clinical trials through clinical trial institution filing management,and provide recommendations for controlling the quality risk of Phase Ⅰclinical trials. Methods: Risk management theory,literature research methods,and expert interviews were used to identify risk indicators affecting the quality of drug phase Ⅰ clinical trials. The importance of risk indicators was assessed through expert questionnaires and analytic hierarchy process,and weights for each risk indicator were obtained. Then,we put forward some suggestions. Results: Under the filing system of clinical trial institution,the communication of drug clinical trials and the establishment of drug clinical trials were very important in the phaseⅠ clinical trials of drugs. Review and approve of drug clinical trials,and evaluation of phase Ⅰ clinical trial organizations by sponsors or third parties also had a certain influence on the quality of clinical trials. Conclusion:Risk factors,such as communication of drug clinical trials,establishment of drug clinical trials,review and approve of clinical trials of drugs,and evaluation of phase Ⅰ clinical trial organizations by sponsors or third parties,should be controlled for improving the quality of phase Ⅰ clinical trials.
Objective: Identify and evaluate risk indicators for the impact of phase Ⅰ clinical trials through clinical trial institution filing management,and provide recommendations for controlling the quality risk of Phase Ⅰclinical trials. Methods: Risk management theory,literature research methods,and expert interviews were used to identify risk indicators affecting the quality of drug phase Ⅰ clinical trials. The importance of risk indicators was assessed through expert questionnaires and analytic hierarchy process,and weights for each risk indicator were obtained. Then,we put forward some suggestions. Results: Under the filing system of clinical trial institution,the communication of drug clinical trials and the establishment of drug clinical trials were very important in the phaseⅠ clinical trials of drugs. Review and approve of drug clinical trials,and evaluation of phase Ⅰ clinical trial organizations by sponsors or third parties also had a certain influence on the quality of clinical trials. Conclusion:Risk factors,such as communication of drug clinical trials,establishment of drug clinical trials,review and approve of clinical trials of drugs,and evaluation of phase Ⅰ clinical trial organizations by sponsors or third parties,should be controlled for improving the quality of phase Ⅰ clinical trials.
引文
[1]国家食品药品监督管理局.药品注册管理办法[M].北京:中国法制出版社,2007.
[2]刘业娜,刘韬,王艺,等.Ⅰ期临床试验的规范化管理[J].今日药学,2017,27(4):274-277.
[3]王周伟.风险管理[M].北京:机械工业出版社,2012:3.
[4]国家食品药品监督管理总局.关于调整药物临床试验审评审批的公告(征求意见稿)[EB/OL].(2017-12-11)[2018-07-27]. http://www. sda. gov. cn/WS01/CL0050/219216. html.
[5]刘晶晶,武志昂.建立我国药品专利链接制度的专家调查研究[J].中国新药杂志,2016,25(11):1206-1211.
[2]刘业娜,刘韬,王艺,等.Ⅰ期临床试验的规范化管理[J].今日药学,2017,27(4):274-277.
[3]王周伟.风险管理[M].北京:机械工业出版社,2012:3.
[4]国家食品药品监督管理总局.关于调整药物临床试验审评审批的公告(征求意见稿)[EB/OL].(2017-12-11)[2018-07-27]. http://www. sda. gov. cn/WS01/CL0050/219216. html.
[5]刘晶晶,武志昂.建立我国药品专利链接制度的专家调查研究[J].中国新药杂志,2016,25(11):1206-1211.