试验机构与申办方对临床试验合同审查的对比分析与对策建议  

Comparative analysis and countermeasures of clinical trial contract review between trial institutions and sponsors

作　　者：曹烨[1] 贺瑜 郭颖[1] 叶林淼 曹伟钊 洪明晃[1] CAO Ye;HE Yu;GUO Ying;YE Lin-miao;CAO Wei-zhao;HONG Ming-huan(Cancer Center of Sun Yat-sen University,Guangzhou 510060,China;Jiangmen General Hospital of Jiangmen,Jiangmen 529030,China;Jieyang People's Hospital,Jieyang 522000,China;General Hospital of Dongguan Songshan Lake,Dongguan 523326,China)

机构地区：[1]中山大学肿瘤防治中心,广州510060 [2]江门市中心医院,江门529030 [3]揭阳市人民医院,揭阳522000 [4]东莞市松山湖中心医院,东莞523326

出　　处：《中国新药杂志》2020年第19期2205-2213,共9页Chinese Journal of New Drugs

摘　　要：目的:临床试验合同是规范试验机构与申办方责权利的重要文件,可有效防范风险并保障试验顺利开展。为更好地了解双方审查合同的现况和存在争议点,深入分析合同审查效率不高的可能因素,本研究对251家试验机构和95家申办方展开调研。方法:通过"临床试验合同审核调研问卷"机构卷和申办方卷,于2020年4月17~26日开展调研。结果:双方参与审查合同的人员的教育背景或专业,对部分限制性条款的接受度差异较大;双方对特殊条款所感知的谈判难度非常吻合;双方对合同争议所采取的解决方式基本吻合。结论:本研究认为试验机构中有必要配备专门的律师、财务、审计人员参与试验合同审查;建议申办方主动与试验机构协商合同模板;建议官方能出台指引或行业对共识不断进行完善,推进临床试验项目的高效启动。Objective:The clinical trial contract is an important document to standardize the rights,responsibilities and obligations of the research institution and the sponsor,which can effectively prevents risks and guarantees the smooth development of the trial.In order to have a better understanding of the current situation and the controversial points of the contract review by both parties and to make an in-depth analysis of the possible factors of low efficiency in the contract review,this study conducted a survey on 251 research institutions and 95 sponsors.Methods:The survey was conducted from April 17 to 26,2020 based on the institutional questionnaire and the sponsor questionnaire.Results:Both parties differ greatly in the educational background or profession of the persons involved in the contract review,as well as the acceptability of some restrictive terms.The difficulties perceived in negotiating particular terms were very similar.The settlement methods adopted by both parties are basically identical with each other.Conclusions:This study believes that it is necessary for the research institutions to possess special staffs like lawyers,financial staffs,and auditors to participate in the review of the clinical trial contract.It is suggested that the sponsor takes the initiative to negotiate the contract template with the research institution.It is also suggested that the government can issue guidelines or the industry can continuously improve the consensus to promote the efficient launch of the clinical trial.

关 键 词：合同审查 临床试验 调研问卷 问题与对策 

分 类 号：R969.4[医药卫生—药理学]