今日药学

2022, v.32(03) 202-205

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新冠疫情背景下临床试验受试者补偿采用第三方平台支付的可行性探讨
Discussion on the Feasibility of Using the Third-party Platform to Compensate the Clinical Trial Subjects in the Background of COVID-19

苏钿欢;周颖;肖蕾;杨若琳;熊红品;杨旭;黄凯鹏;
SU Tianhuan;ZHOU Ying;XIAO Lei;YANG Ruolin;XIONG Hongpin;YANG Xu;HUANG Kaipeng;Guangzhou Eighth People′s Hospital, Guangzhou Medical University;

摘要(Abstract):

目的 探讨新冠疫情背景下临床试验受试者补偿采用第三方平台支付的可行性。方法 以笔者所在的临床试验机构为例,分析对比传统受试者支付模式和第三方平台支付的优劣势。结果 第三方平台支付存在受试者安全信息泄露、违规操作、法律风险等问题,解决措施包括:(1)临床试验机构与申办者、第三方支付平台签署三方协议,共同监督、规范受试者补偿发放行为;(2)申办者、CRO及SMO公司加强相关人员GCP及法律意识培训,严格规范受试者补偿发放的各环节流程;(3)政府监管部门加强对第三方支付平台信息安全的监督指导,以保障受试者信息权益不受伤害。结论 新冠疫情背景下,第三方平台支付可能是目前解决受试者补偿快速、便捷、简易发放的有效、可行办法。
OBJECTIVE To explore the feasibility of using the third-party platform to compensate the clinical trial subjects in the background of COVID-19. METHODS Taken the author′s clinical trial institution as an example, the advantages and disadvantages between the traditional subject payment mode and third-party platform payment mode were analyzed and compared. RESULTS The third-party platform had some problems including subjects safety information disclosure, illegal operation, and legal risk.The solutions were as follows:(1) The clinical trial institution signed a tripartite agreement with the sponsor and the third-party payment platform to supervise and standardize the process of each link of subject compensations payment together;(2) The sponsor and SMO company would strengthen GCP and legal awareness training for relevant personnel, standardize the process of each link of subject compensations payment strictly;(3) Government regulators would strengthen supervision and guidance on the information security of third-party payment platforms to protect the rights and interests of subjects. CONCLUSION Under the background of COVID-19, the third-party platform payment may be an effective and feasible way to solve the distribution of subject compensations at present rapidly, conveniently and simply.

关键词(KeyWords): 新冠肺炎;临床试验;受试者补偿;第三方平台支付
COVID-19;clinical trial;subject compensations;third party platform payment

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作者(Authors): 苏钿欢;周颖;肖蕾;杨若琳;熊红品;杨旭;黄凯鹏;
SU Tianhuan;ZHOU Ying;XIAO Lei;YANG Ruolin;XIONG Hongpin;YANG Xu;HUANG Kaipeng;Guangzhou Eighth People′s Hospital, Guangzhou Medical University;

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