摘要
目前涉及人类遗传资源领域的临床试验项目不断增多,但在实际操作中仍存在许多问题。药物临床试验机构如何合理应用和有效保护我国的人类遗传资源,本文将根据临床试验项目的整个发生过程,依次从立项、伦理审评、签订合作协议、项目启动、临床试验过程等各个方面,从可能遇到的问题到梳理相关政策再到机构采取的具体措施进行探索。通过积极的遗传资源管理,促进临床试验机构的建设,为我国的人类遗传资源管理做出一份贡献。
At present, as good clinical trials involving Chinese human genetic resources increase, however, there are still some problems in practice. How to use and manage human genetic resources effectively in clinical trial institution. In this letter, according to the whole process of clinical trial, from setting up the project, ethical review, cooperation agreement, initiation and clinical trials process, we will explore from the possible problems, to comb the related policy, institutional measures. Through active management of genetic resources, to promote the construction of clinical trial institution, and make a contribution to the management of Chinese human genetic resources.
作者
唐蜜
邢莎莎
徐鸣
蔡江晖
杨霄
TANG Mi;XING Shasha;XU Ming;CAI Jianghui;YANG Xiao(Good Clinical Practice Institution,Chengdu Women’s and Children’s Central Hospital,School of Medicine,University of Electronic Science and Technology of China,Chengdu,Sichuan 611731,China;Department of Pharmacy,Chengdu Women’s and Children’s Central Hospital,School of Medicine,University of Electronic Science and Technology of China,Chengdu,Sichuan 611731,China)
出处
《中国优生与遗传杂志》
2022年第2期340-343,共4页
Chinese Journal of Birth Health & Heredity
基金
四川省科技厅重点研发计划(重大科技专项)(22ZD YF1597)
成都市重大科技应用示范项目(2021-YF09-00048-SN)
成都市医学科研课题(2020216)。
关键词
临床试验
临床试验机构
人类遗传资源
clinical trial
clinical trial institution
human genetic resource
