智能化临床研究中美法规环境对比分析  

Comparative Study on Chinese and American Virtual Trial Regulations

作　　者：吴瑶 吴维娟 张庆[1] 马延 WU Yao;WU Wei-juan;ZHANG Qing;MA Yan(China Pharmaceutical University)

机构地区：[1]中国药科大学 [2]艾昆纬医药科技有限公司

出　　处：《中国食品药品监管》2020年第11期117-124,共8页China Food & Drug Administration Magazine

摘　　要：智能化临床研究采用智能设备及远程通信技术,实现线上完成知情同意、试验药物直接送达患者家中、远程监查、试验数据实时上传,大大提高了临床试验的效率和质量。受新冠肺炎(COVID-19)疫情影响,我国药物临床试验智能化逐步提上进程,但与美国相比,相关法律的系统性、科学性和可操作性等还有待完善。本文从中美两国智能化临床研究相关法规研究角度出发,分析中美智能化临床研究的政策现状、差异及各自特点,对目前我国智能化临床研究发展过程中存在的问题提出解决建议,以期为进一步完善我国智能化临床研究法规体系提供参考。Virtual trial uses intelligent devices and remote communication technology to greatly improve the efficiency and quality of clinical trials via electronic informed consent,direct to patient home delivery of investigational drugs,remote monitoring,and real-time upload of clinical trial data.Under the impact of the COVID-19 epidemic,virtual trial is gradually applied in China.However,comparing with the US,the systematic,scientific as well as operational aspects of related regulations in China still waits for improvement.This paper analyzes the policy status,differences and characteristics of the virtual trial between China and the United States from the perspective of related regulations,proposes solution and suggestion to the problems in current development of virtual trial in China,and provides reference for improving regulation system of virtual trial in our country.

关 键 词：临床试验 智能化临床研究 中美法规 电子知情 远程监查 

分 类 号：R95[医药卫生—药学]