PDCA循环理论在药物临床试验机构中的应用  

Application of PDCA Cycle Theory in Interest Conflict Management of Clinical Trial

作　　者：薛源[1] 郭晋敏[2] 康长清[2] 舒鹤[2] 张莉[2] 

机构地区：[1]济南军区总医院医疗科,济南250031 [2]济南军区总医院药剂科,济南250031

出　　处：《解放军医院管理杂志》2016年第3期213-217,共5页Hospital Administration Journal of Chinese People's Liberation Army

摘　　要：目的促进本院药物临床试验机构利益冲突的规范化管理,减少利益冲突。方法应用PDCA循环对临床试验利益冲突开展专项管理,实施措施包括制定机构内利益冲突政策、强化培训、加强机构监管职能、接受各方监督。检查知识的掌握程度及利益冲突政策的落实情况,发现存在的不足,有针对性地采取措施提高机构对利益冲突的收集能力、研究人员识别利益冲突的能力和主动上报意识。整改前后,通过问卷的形式调查研究人员对利益冲突的认知程度,统计各调查要点的正确回答及"不清楚"回答的比例,整改前后相比较以反映PDCA干预效果。结果经过PDCA专项整治后,研究人员对利益冲突的认知程度显著提高,各调查要点的正确回答比例显著提高(P<0.001),"不清楚"回答的比例显著降低(P<0.001)。同时,强化研究人员对利益冲突的敏感性及主动上报意识,提高机构对利益冲突的收集能力。结论利用PDCA循环显著提高机构对利益冲突的识别及管理能力,机构初步建立利益冲突的规范化管理。Objective To promote standardized management of interest conflict in clinical trial. Methods PDCA cycle was applied in special activities for interest conflict in clinical trial,Implementation measures included formulating the policy of conflict of interest,strengthening training and regulatory functions of the institution,and accepting supervision of the parties. The problem was found by checking grasping state of the knowledge and the implementation of the policy of interest conflict. Then targeted measures were taken to improve the ability of collecting interest conflict of the organization,the ability of identifying interest conflicts and actively report awareness for researchers. the mastering degree of interest conflict before and after Rectification were investigated by questionnaire survey,Proportion of correct answers and ＂not clear＂answer of each point of investigation were compared and analyzed. Results After the special activities,proportion of correct and ＂not clear＂answers of each point significantly increased（ P 0. 001）. The ability of identifying interest conflicts and actively report awareness for researchers was improved,as well as the ability of collecting interest conflict for the organization. Conclusion The special activities with PDCA significantly improved finding and report of interest conflict. The standardization management of interest conflict is initially established.

关 键 词：利益冲突 临床试验 PDCA 

分 类 号：R197.32[医药卫生—卫生事业管理]