Discussion on the management and implementation of clinical research on foreign subjects in China
LIU Xiao-hui
LI Ke-xin
BAI Wen-jing
WANG Juan
CONG Duan-duan
XU Xiao-yu
LIU Yue
QI Wen-yuan
XUE Wei
Abstract：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.
Keywords：clinical trialcaucasian subjectssubject management
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2540-2543 )