药物临床试验伦理审查质量风险的管理研究

Study on Quality Risk Management of Ethical Review of Drug Clinical Trials

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。

OBJECTIVE:To provide suggestions for improving the quality of ethical review of drug clinical trials in China and protecting the rights and interests of subjects.METHODS:Guided by risk management theory,the literature research method,expert opinion method and analytic hierarchy process method were used to sort out the ethical review process of drug clinical trials,extract and determine the risk factors that affect the quality of ethical review,and determine the weight of each risk factor.Suggestions were put forward improving the ethical review of drug clinical trials in China.RESULTS&CONCLUSIONS:Established ethical review risk index system of drug clinical trials included 31 influential factors of 5 aspects;the order of importance(weights)of 5 aspects affecting the quality of ethical review of drug clinical trials was as follows:the construction of the medical ethics committee(0.2635),the management of review meetings(0.2514),follow-up review(0.1945),the acceptance and processing of review applications(0.1892),and the management of documents and files(0.1014).The influential factors with high weight included"withdrawal of people with conflict of interest in the discussion and voting process(0.0787)""timely review or conference discussion of scheme modification,informed consent modification,serious adverse events,etc.(0.0705)""clarification and external exhibition of the work process and time of ethical review(0.0598)""unified and standardized review standards and approval standards(0.0521)",etc.The quality of ethical review can be improved by avoiding people with conflict of interest in the discussion and voting process,timely reviewing or holding ethics meetings on scheme modification,informed consent modification,serious adverse events,etc.,clarifying the working process and time of ethical review,and establishing unified and standardized review standards and approval standards.