中国药物临床试验机构人类遗传资源管理现状调研

Investigation on the current situation of human genetic resources management in Chinese drug clinical trial institutions

目的调研中国药物临床试验机构人类遗传资源管理的现状,分析原因并提出建议。方法随机选取214家中国药物临床试验机构通过微信问卷形式针对人类遗传资源管理机构/部门设置、管理文件体系的建立、法规培训学习、监管、生物标本库的建立、接受检查情况等方面开展了调研。结果在调查的214家医院中,22%的医院未设置人类遗传资源管理机构/部门;医院层面和药物临床试验机构层面分别有33%和23%的医院未建立人类遗传资源管理文件体系;医院层面和药物临床试验机构层面分别有44%和17%的医院对人类遗传资源管理相关法规未开展任何形式的培训学习;医院层面和药物临床试验机构层面分别有44%和30%的医院对人类遗传资源事宜未进行监管或没有监管记录。结论医院和药物临床试验机构应加强对人类遗传资源的管理。

Objective To investigate the present situation of the human genetic resources(HGR) management for drug clinical trial institution in china, to analyse the causes and provide suggestions. Methods 214 drug clinical trial institutions in China were chosen randomly to fill in a WeChat questionnaire on HGR management such as management depart-ment settings, establishment of the management system documents, training on rules and regulations, supervision, establishment of the biobank and inspection by the government. Results 22% of the hospitals had not set up the HGR management department. 33% and 23% of the hospitals had not established management system documents of HGR at the level of hospital and drug clinical trial institution, respectively.44% and 17% of the hospitals had not carried out any training on rules and regulations of HGR at the level of hospital and drug clinical trial institution,respectively. Conclusion Both hospitals and drug clinical trial institutions should strengthen the management of HGR.