新药临床桥接试验的文献计量分析

发布时间：2018-06-09 17:05

本文选题：桥接试验 + 药物临床试验　；参考：《中国临床药理学杂志》2015年21期

【摘要】：目的检索国内外与桥接试验相关的文献资料,了解桥接试验的研究进展和现状。方法检索截止至2015年3月Pubmed、Embase、Web of Science以及中国知网数据库,用End Note X7整理,对文献类型、发表年份、第一作者、研究机构、发表期刊、被引频次、样本量和研究内容进行计量分析。结果共纳入外文文献98篇,中文文献8篇。第一篇文献于1993年发表,自1998年关于桥接试验的文献波动增加。发文量最多的是美国,发表最多的期刊是生物药剂统计学杂志,发表最多的研究机构是加利福尼亚临床试验中心,最高被引120次。具体样本量在50以下的文献超过一半。研究内容涉及种族敏感性、桥接研究的类型及桥接策略的模式等。结论桥接试验被广泛关注,但仍需更多临床研究数据以待更深入的探索。
[Abstract]:Objective to search the literature related to bridging experiment at home and abroad and to find out the research progress and present situation of bridging experiment. Methods until March 2015, Pubmedus Embase of Science and China knowledge Network database were searched. The literature types, the year of publication, the first author, the research institution, the published journals, the frequency of citation, the sample size and the contents of the study were analyzed quantitatively with end Note X7. Results 98 foreign literature and 8 Chinese literatures were included. The first paper was published in 1993 and the fluctuation of the literature on bridging experiments has increased since 1998. The most published journal was the Journal of Biopharmaceutical Statistics, and the most widely published research institute was the California Center for Clinical Trials, with up to 120 citations. More than half of the literature with specific samples below 50. The research involves race sensitivity, types of bridging studies and patterns of bridging strategies. Conclusion the bridging test is widely concerned, but more clinical data are needed for further exploration.
【作者单位】：中国人民解放军总医院转化医学中心药物临床研究中心;天津医科大学药学院;
【基金】：国家科技部十二五重大专项滚动课题基金资助项目(2012ZX09303004-002)
【分类号】：R969.4

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