广东药科大学学报2025，Vol.41Issue(5)：13-19,7.DOI:10.16809/j.cnki.2096-3653.2025060903
中国产科药物临床试验资源分布与试验现状多维分析及优化策略研究
A multi-dimensional analysis of the distribution and status quo of clinical trials of obstetrics drugs in China and its optimal strategies
摘要
Abstract
Objective To analyze the distribution characteristics and status quo of obstetric institutions,principal investigators(PI)and experimental projects in China,to reveal the key problems of resource allocation and propose the optimization path.Methods The data of the National Platform for Drug Clinical Trial Registration(up to December 17,2024)and the National Platform for Drug Clinical Trial Registration and Information Publication(up to December 25,2024)were extracted.ArcGIS 10.8 was used for spatial visualization analysis,and SPSS 26.0 was used for the overall planning description and Pearson correlation test(α=0.05).Results Of the 1 665 registered institutions in the country,there were 140 registered obstetric institutions(8.41%),including 117 general hospitals(83.57%),and 23 obstetrical and gynecological hospitals(16.43%).Among 38 914 registered PIs,326(0.84%)were obstetrics specialist PIs.Eight provinces,including Guangdong(19)and Beijing(16),accounted for 61.43%of the national institutions and 70.25%of the PIs,and five provinces,including Xizang and Qinghai,were in a state of"zero institutions".Of the 27 364 registered clinical trials,only 95(0.35%)were perinatal trials,of which only 8(8.42%)were key trials in phase Ⅱ/Ⅲ/Ⅳ,conducted by 4 institutions in 4 provinces.The trial types were dominated by biological equivalence(78,82.10%),and the insurance coverage rate for participants was 54.74%(52).Conclusion There are three contradictions in clinical trials of obstetrics,which are"uneven allocation of resources,imbalance of spatial distribution and lack of projects".关键词
产科/药物临床试验/空间分布/围产期/多中心协作/伦理审查/数字化技术Key words
obstetrics/clinical trials of drugs/spatial distribution/perinatal period/multicentre collaboration/ethics review/digital technologies分类
医药卫生引用本文复制引用
周伶俐,李凌云,周恒郁,陈海云..中国产科药物临床试验资源分布与试验现状多维分析及优化策略研究[J].广东药科大学学报,2025,41(5):13-19,7.基金项目
湖南省儿童安全用药临床医疗技术示范基地基金资助项目(2023SK4083) （2023SK4083）
