摘要
目的在新政策的推动下,分析苏州地区药物临床试验开展现状。方法通过“国家药物临床试验登记与信息公示平台”进行网络检索,对苏州地区药物临床试验机构分布、备案专业、临床试验开展情况等进行数据统计。结果苏州地区药物临床试验机构数量居江苏省前列,备案的主要研究者与承接临床试验的数量也靠前,临床试验的开展在严格监管体系下进行,但仍存在申办方积极性不足,研究者临床试验知识掌握不够,伦理审查不够规范,备案专业分布不均衡、可以开展Ⅰ期的临床试验机构偏少等问题。结论仍需开放临床试验鼓励政策,建设区域临床试验合作平台,加大临床试验监管力度,促进临床试验合理发展。
Objective Spurred on by new policies,the current situation of drug clinical trials in Suzhou was analyzed.Methods Data statistics was performed for the organization distribution of drug clinical trials,record speciality,current situation of clinical trials in Suzhou by searching the“www.Chinadrugtrials.org.cn”website.Results The number of drug clinical trial institutions,principal investigators and clinical trials undertaken in Suzhou ranks forefront of Jiangsu province.Clinical trials are carrying out under a tightly regulated system,however,there still exists many problems such as the sponsors lack of positivity,investigators lack of knowledge of clinical trials,the ethic review is not standard enough,the distribution of record majors is unbalanced and there are only a few institutions that can conduct phase I clinical trials.Conclusion More clinical trial encouragement policies should be introduced,the regional clinical trials cooperation platform should be established and the supervision of clinical trials should be stricter to encourage the healthy development of clinical trials.
作者
周历彬
陈亚芳
文婷婷
ZHOU Li-bin;CHEN Ya-fang;WEN Ting-ting(Department of pharmacy,the First People’s Hospital of Kunshan,Kunshan 215300,China)
出处
《中国处方药》
2022年第10期1-3,共3页
Journal of China Prescription Drug
关键词
苏州地区
药物临床试验
数据统计
现状分析
临床试验监管
Suzhou district
Drug clinical trials
Data statistics
Status analysis
Clinical trials supervision
