中国临床药学杂志2025，Vol.34Issue(6)：408-413,6.DOI:10.19577/j.1007-4406.2025.06.002
备案制下我国妇产科药物临床试验实施SWOT分析和对策研究
The SWOT analysis and strategy research on the implementation of drug clinical trials in obstetrics and gynecology under registration system in China
摘要
Abstract
AIM To comprehensively analyze the internal factors and external environment of the implementation of drug clinical trials in obstetrics and gynecology,and put forward development strategies and suggestions.METHODS Based on SWOT analysis,the advantages,disadvantages,opportunities and threats of the development of clinical trials for obstetrics and gynecology drugs in medical institutions were analyzed,and development strategies and improvement measures were sought.RESULTS The obstetrics and gynecology medical institutions have advantages and opportunities in conducting clinical drug trials such as having more opportunities to participate in drug clinical trials,more emphasis on quality process supervision,more comprehensive drug clinical trial regulations and flourishing drug registration.However,there are problems of insufficient understanding of drug clinical trials,special subject populations,concentrated project implementation,and inadequate research and development investment.CONCLUSION Medical institutions with obstetrics and gynecology should seize opportunities by enhancing their capabilities,strengthening the construction of the research team,adjusting professional development strategies,and building drug clinical trial platforms to promote the development of the drug clinical trial industry of obstetrics and gynecology drugs.关键词
备案制/妇产科/药物临床试验/SWOT分析Key words
registration/obstetrics and gynecology/drug clinical trial/SWOT analysis分类
医药卫生引用本文复制引用
丁宏,何高丽,曾涛,张炜,张晓燕,洪璐,袁兰芳,黄艳梅,姜桦..备案制下我国妇产科药物临床试验实施SWOT分析和对策研究[J].中国临床药学杂志,2025,34(6):408-413,6.基金项目
上海申康医院发展中心促进市级医院临床技能与临床创新能力三年行动计划(编号20CR4004B) （编号20CR4004B）
