我国境内开展外籍受试者临床研究的流程管理探讨

Discussion on the management and implementation of clinical research on foreign subjects in China

随着我国加入ICH及一系列ICH指导原则陆续实施,我国医药创新体系与国际接轨和互认升级、深度融入全球创新体系,境外申报数据可用于我国新药上市申请,制药企业全球同步研发和注册能力日益提升。在为桥接国外临床数据而设计的临床试验中,越来越多涉及纳入健康外籍受试者。针对健康外籍受试者临床研究的管理流程与健康中国受试者研究的异同、应注意的要素,本文以一项纳入高加索受试者的Ⅰ期临床试验为例,分享和探讨纳入外籍受试者临床研究的执行和管理经验。

With China's accession to ICH and implementing a series of ICH guidelines,the pharmaceutical innovation system of China has been in line with international standards and deeply integrated into the global innovation system,making overseas declaration data can be used in China's new drug marketing application.The ability of global synchronous investigation and registration has been largely improved along with these development.Clinical trials gradually need to involve healthy foreign subjects,especially those who need to be compared in the pharmacokinetic characteristics of different races in order to bridge the existing data abroad.What are the similarities and differences between the management process of clinical research on healthy foreign subjects and their Chinese counterparts?What factors should be paid attention to?This article takes a phase I clinical trial involving Caucasian subjects as an example to share and discuss the implementation and management experience of clinical studies involving foreign subjects to answer these questions.