摘要
Ⅰ期临床试验是初步的临床药理学及人体安全性评价的试验,近年来,随着创新药物研发步伐的加快,江苏省Ⅰ期药物临床试验专业备案数量和承接项目数量呈增长趋势,但省内承接Ⅰ期药物临床试验项目集中在头部机构,新备案Ⅰ期药物临床试验专业的机构承接项目较少。本文通过检索药物临床试验登记与信息公示平台和药物临床试验机构备案管理信息系统,收集近年来江苏省Ⅰ期药物临床试验专业的数量、专业的建设情况、项目承接情况等信息,对江苏省药物临床试验机构Ⅰ期药物临床试验专业的发展现状进行数据分析,结合机构的发展趋势和特点,对Ⅰ期临床试验专业的建设和发展提出相关建议。
PhaseⅠclinical trials are preliminary trials of clinical pharmacology and human safety evaluation.In recent years,with the acceleration of innovative drug research and development,the number of phaseⅠdrug clinical trial records and the number of projects undertaken in Jiangsu Province have shown an increasing trend,but the projects undertaken in the province are concentrated in head institutions,fewer are undertaken by newly recorded phaseⅠdrug clinical trial professional institutions.By searching the drug clinical trial registrations,the information publicity platform and the record management information system of drug clinical trial institutions,this paper collected information such as number and construction of phaseⅠdrug clinical trial professionals and projects undertaken in Jiangsu Province in recent years,and conducted data analysis on the development status of phaseⅠdrug clinical trial professionals.Based on the development trend and characteristics of the institutions,some suggestions are put forward for the construction and development of PhaseⅠclinical trial professionals.
作者
田媛
徐厚明
刘春帅
胡晨希
TIAN Yuan;XU Houming;LIU Chunshuai;HU Chenxi(Center for Inspection of JSMPA,Nanjing 210019,China)
出处
《药学与临床研究》
2024年第2期179-183,共5页
Pharmaceutical and Clinical Research
关键词
Ⅰ期药物临床试验专业
数据分析
发展趋势和特点
建议
PhaseⅠdrug clinical trial specialty
Data analysis
Development trends and characteristics
Suggestion
