多中心药物临床试验项目立项至启动耗时分析

Analysis on Time-consuming of Multi-center Drug Clinical Trial Project from Approval to Start-up

关键词:  多中心药物临床试验  立项  启动  审查效率  合同模板

Key words:  multi-center drug clinical trial  approval  start-up  review efficiency  contract template

摘要:

目的 探讨如何缩短临床试验立项至启动的耗时。方法 选取南宁市第一人民医院2020-2021年期间启动的Ⅱ~Ⅲ期多中心药物临床试验项目22项,分析启动前各环节的耗时情况,比较申办方和研究机构在立项审批、伦理审查和合同审签的耗时,并比较使用不同合同模板时对合同审签耗时的影响。结果 合同审签耗时最长;立项审批、伦理审查和合同审签3个环节中申办方和研究机构各方的耗时未见明显差异;使用研究机构的合同模板,申办方和研究机构在审稿环节的耗时以及项目的合同签署耗时都更短。结论 使用临床试验管理系统,开展差异化伦理审查方式,前置药品寄送和承诺书递交,使用研究机构合同模板或签订框架合同,建立行之有效的沟通方式都是缩短启动前耗时的有效途径。

Abstract:

OBJECTIVE To explore how to shorten the time from approval to start-up of drug clinical trial project. METHODS Twenty-two phase Ⅱ-Ⅲ multi-center drug clinical trial projects start up in The First People's Hospital of Nanning from 2020 to 2021 were selected. The time-consuming of each link before the launch was analyzed, and the time- consuming of project approval, ethical review and contract review between the sponsor and research institution was compared, as well as the influence of using the contract template of each party on the time-consuming of contract review was compared. RESULTS Contract review took the longest time. There was no significant difference in the time-consuming between the sponsor and the research institutions in the three links of project approval, ethical review and contract review. Used the contract template of the research institutions, the time spent by the sponsor and the research institution in the review process, as well as the contract signing time of the project were shorter. CONCLUSION Using the clinical trial management system, conduct differentiated ethical review methods, advance drug delivery and commitment letter submission, use the contract template of research institutions or sign a framework contracts, establish a effective communication methods are all effective ways to reduce the time taken before start-up.