中国临床药学杂志

目的 综合分析妇产科药物临床试验实施的内部因素和外部环境，提出发展策略和建议。方法 采用SWOT分析法（态势分析法），对备案制下医疗机构发展妇产科药物临床试验的优势、劣势、机会和威胁进行分析，寻找专业发展策略与改进措施。结果备案制下妇产科医疗机构开展药物临床试验具有优势和机会，包括参与药物临床试验机会更多、监管机构更加注重质量/过程监管、药物临床试验法规逐步完善、药品注册发展蓬勃等；同时存在研究者对药物临床试验重视程度不够、受试人群特殊、项目开展集中、研发投入有限等问题。结论 妇产科医疗机构应抓住机遇，通过提升自身能力建设、加强研究者队伍建设、调整专业发展策略及搭建妇产科药物临床试验平台等举措，促进妇产科药物临床试验发展。

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.