简介:摘要目的了解国内药物临床试验相关伦理审查研究的发展动态,为今后的研究提供参考依据。方法通过检索中国知网和万方全文数据库,回顾2003—2020年间国内药物临床试验相关伦理审查研究的文献资料,采用文献计量学和可视化方法对文献的发文量、期刊分布、文献作者和关键词等进行统计分析。结果纳入符合标准的文献336篇,文献发文量呈缓慢增长趋势,公开发表在107种期刊上;《中国医学伦理学》杂志载文量最多(53篇);南京中医药大学附属医院参与发文量最多;北京、江苏和上海地区的医疗和科研机构发文排前3位;熊宁宁、刘海涛、陆麒、汪秀琴和吴翠云合作研究强度最大;近年研究热点以受试者保护、跟踪审查、多中心临床试验、孕妇受试者、儿童临床试验、药物临床试验质量管理规范和新型冠状病毒肺炎为主;获得11种省级以上研究基金的资助。结论通过文献计量和可视化的手段,对广大研究者梳理本领域知识结构、进展情况,寻求合作交流,改进不足和论文投稿等均有参考作用。
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