从研究者发起的临床研究“资助合同”审查引发的思考和建议  

Thoughts and suggestions arising from the review of the clinical research “funding contract” initiated by investigator

作　　者：曹烨[1] 洪明晃[1] 陈明弟 许然[1] 孙健[1] 李苏[1] 丁小倩[3] 范瑞泉 刘亚卿 CAO Ye;HONG Ming-huang;CHEN Ming-di;XU Ran;SUN Jian;LI Su;DING Xiao-qian;FAN Rui-quan;LIU Ya-qing(Clinical Research Department/Drug Clinical Trial Institute,Cancer Prevention Center,Sun Yat-Sen University,Guangzhou 510275,China;Department of Pharmacy,People’s Hospital of Yunfu City,Yunfu 527300,China;Medical Insurance Office,Medical Office,Cancer Prevention Center,Sun Yat-sen University,Guangzhou 510275,China;Science Institute of Sun Yat-sen University,Guangzhou 510275,China;Shanghai Pudong Wuxin Insurance Broker Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]中山大学肿瘤防治中心临床研究部/药物临床试验机构,广州510275 [2]广东省云浮市人民医院药学部,云浮527300 [3]中山大学肿瘤防治中心医务处医保办公室,广州510275 [4]中山大学科学研究院,广州510275 [5]上海浦东五新保险经纪有限公司,上海201203

出　　处：《中国新药杂志》2020年第17期2000-2008,共9页Chinese Journal of New Drugs

摘　　要：近年来,研究者发起的临床研究(investigator initiated trial, IIT)快速增长, IIT项目管理的各类问题也日益显现。本文从IIT项目的合同审查角度,通过对我院2018年1月—2019年12月期间受理的150份IIT项目"资助合同",对合同的一般特征及审查常见问题进行回顾统计分析。结果显示:150份IIT资助合同以中文文本为主、与医药公司直接签署为主、内企资助合同为主、Ⅱ/Ⅲ期临床研究为主、干预性临床研究为主、资助方与研究用药品存在关联为主。常见问题表现为:54.4%的IIT论文发表权利受限,28.16%的IIT知识产权归属存争议,66.67%的项目未提供保险, 54.67%的IIT项目不提供免费研究用药品,受试者损害赔偿和研究药品产品质量问题承担主体不清、利益冲突声明制度有待加强等。根据上述分析结果,本文分别从对IIT的资助、结果发表的无偏倚原则、利益冲突声明、知识产权保护意识、受试者权益和医院赔付压力、医保资源隐患、合同审查规范化、医疗机构是否应该设立IIT专管部门等提出了思考和建议。The investigator initiated trials(IITs) have increased rapidly in recent years, and various management problems of IIT project have become gradually apparent. From the perspective of contract review of IIT project, this paper reviews the general characteristics of the contract and the common critical problems throughout the review of 150 "funding contracts" of IIT project received by our hospital from January 2018 to December 2019 retrospectively. The results show that these contracts were mainly written in Chinese, directly signed with pharmaceutical companies, supported by domestic enterprises, phase Ⅱ/Ⅲ of clinical researches, intervention clinical researches, and funded by pharmaceutical company or pharmacy-related associations. The common problems are as follows: 54.4% of the IIT papers have limited right to be published, 28.16% of the IIT intellectual property rights are disputed, 66.67% of the projects do not provide insurance, 54.67% of the IIT projects do not provide free research drugs, the bearing body of damage compensation and research drug product quality issues are unclear, conflict of interest statement system needs to be strengthened. According to the above analysis results, this paper puts forward some thoughts and suggestions from the funding of the IIT, the unbiased principle of the results, the statement of conflict of interest, the awareness of intellectual property protection, the rights and interests of subjects and the pressure of hospital compensation, the hidden dangers of medical insurance resources, and the standardization of contract review, as well as whether medical institutions should set up IIT specialized departments. It is of great significance for the medical community to establish a good IIT management system, ensure the quality of research and improve the conversion rate of research results.

关 键 词：研究者发起的临床研究 资助合同 论文发表 利益冲突 知识产权 受试者权益 社会医疗保险 

分 类 号：R95[医药卫生—药学]