某机构药物临床试验自查发现问题及管理措施探讨

Problems found in self-inspection of drug clinical trial in an institution and discussion on management measures

目的对某机构药物临床试验数据自查收集的问题进行分析,探究临床试验开展过程中问题发生原因,提出临床试验质量提高的建议和看法,为项目管理和其他机构提供参考。方法收集某机构156个项目自查发现问题,对照《药品注册核查要点与判定原则(药物临床试验)(试行)》进行分类,对发现问题进行统计和分析。结果130个项目存在违反药品注册核查要点与判定原则的不合格项共计1069项,其中在临床试验许可与条件方面存在不合格项132项(占12.35%);在临床试验实施过程方面存在不合格项799项(占74.74%);在试验用药品管理方面存在不合格项61项(占5.71%);在生物样品管理方面存在不合格项46项(占4.30%)。结论本次研究显示,该机构在临床试验实施过程、临床试验许可与条件两方面发现问题占比较大,建议应完善质量控制模式、开展药物临床试验自查、实施信息化管理,对提高药物临床试验质量具有可借鉴性意义。

Objective Analyze the problems collected from the self-inspection of drug clinical trial data of an institution,explore the causes of the problems in the process of clinical trial,and put forward suggestions and views to improve the quality of clinical trial,providing reference for project management and other institutions.Methods 156 items were collected by self-inspection of of an institution,then classified by the“Key points and principles of drug registration verification(drug clinical trial)(trial)”,and then statistics and analyzed them.Results 130 items had 1069 unqualified items that violated the key points and judgment principles of drug registration verification,among them,there were 132 unqualified items(12.35%)in terms of clinical trial license and conditions;799 unqualified items(74.74%)in terms of the implementation process of clinical trials;61 unqualified items(5.71%)in terms of the management of experimental drugs;46 unqualified items(4.30%)in terms of the management of biological samples.Conclusion This study showed that problems of the instition in the implementation process of clinical trials,licensing and conditions of clinical trials accounted for a large number of problems.It is suggested that it should improve the quality control mode,carry out the self-inspection of clinical drug trials,and implement information management,which has referential significance for improving the quality of drug clinical trials.