美日药物临床试验中重大利益冲突的界定和管理探讨及对我国的启示

Definition and Management of Significant Conflict of Interest in Clinical Drug Trials in America and Japan and Enlightenment to China

目的:为我国界定药物临床试验中重大利益冲突和制订相应的管理措施提出建议。方法:通过介绍利益冲突的概念,探讨美日对重大利益冲突的界定及药物临床试验中利益冲突管理体系(包括管理层次、管理对象和管理方式等),提出我国重大利益冲突的界定和管理建议。结果与结论:在临床试验中,利益冲突可能在研究者个人和研究机构两个层面发生。美国公共卫生署、美国医学院协会、美国《新英格兰医学杂志》,日本医学会均对研究者重大利益进行了界定。美国管理体系可分为联邦、协会以及美国临床试验研究机构和相关学术期刊制订的利益冲突管理政策三个层次;日本利益冲突管理体系的层次包括政府部门和协会;美日不同法规和指南的管理对象均包括主要研究者和其他主要管理对象;美国不同机构的研究者利益冲突管理方式不尽相同,而日本医学会对于研究者的重大利益冲突提出回避的管理方式。在借鉴美日对临床试验中研究者和研究机构的重大利益冲突的界定和管理的基础上,建议我国结合国情和借鉴其他领域法规界定重大利益冲突,对重大利益冲突实行回避管理,并在远期建立多层次的利益冲突管理体系,降低影响受试者安全和试验结果可靠性的风险,提高公众对药物临床试验行业的信任。

OBJECTIVE:To provide suggestions for defining significant conflict of interest and in clinical drug trials formulating relevant management measures in China.METHODS:Through introducing the concept of interest conflict,the definition of significant interest conflict and management system of interest conflict in clinical drug trial were investigated(including management level,management object and management mode).The definition and management recommendations were put forward for significant conflicts of interest in China.RESULTS&CONCLUSIONS:In clinical trials,interest conflicts maybe occurred in researcher and research institutions.United States Public Health Service,Association of American Medical Colleges,American New England Journal of Medicine and the Japanese Medical Association had defined the significant interests of researchers.The American management system could be divided into three levels,namely,the management policy of interest conflict was formulated by the Federation,the Association,the American clinical trial research institutions and the relevant academic journals.Japanese management system of interest conflict included government departments and associations.Management objects of American and Japanese different regulations and guidelines included main researchers and other main management objects.There were different management methods of conflicts of interests among researchers from different institutions in the United States,while the Japanese Medical Association provided a way to avoid the significant conflicts of interest of the researchers.On the basis of the definition and management of significant conflicts of interest in clinical trials between researchers and research institutions in the United States and Japan,it is suggested to define significant conflicts of interest based on national conditions and referring to other laws and regulations of other fields,avoidance management of significant conflicts of interest and establish a long-term multi-level interest conflict management system so as to reduce the risk of affecting the safety of the subjects and the reliability of the test results,and improve public trust on the industry of drug clinical trials.