Bibliometric analysis of bridging study of new drugs
10.13699/j.cnki.1001-6821.2015.21.021
- VernacularTitle:新药临床桥接试验的文献计量分析
- Author:
Kai WANG
1
;
Bei-Bei LIANG
;
Nan BAI
;
He-Kun MEI
;
Ying XU
;
Jin WANG
;
Rui WANG
Author Information
1. 中国人民解放军总医院 转化医学中心 药物临床研究中心
- Keywords:
bridging study;
clinical trial;
clinical data;
bibliometric analysis;
bibliometrics
- From:
The Chinese Journal of Clinical Pharmacology
2015;(21):2153-2155
- CountryChina
- Language:Chinese
-
Abstract:
Abjective To retrieve domestic and international literatures about bridging study, and understand the recent progress and current situation.Methods PubMed, Embase, Web of Science and CNKI were searched to collect all the literatures connected with bridging studies from the beginning to March,2015.Endnote X7 was used to sort out and sum-marize.The type of literature, published year, first author, research in-stitution, published journal, cited frequency, sample size and research contents were analyzed with bibliometric methods.Results A total of 98 foreign articles and 8 Chinese articles were included.The first paper was published in 1993, and then the number rose wavelike since ICH E5 was published in 1998.The top one journal who published the most articles is journal of biopharmaceutical statistics, and the top one research institu-tion who published the most articles is California Clinical Trials.Among them, the most frequently cited paper was cited up to 120 times.The sample size under 50 was more than half of the totality.Ethnic sensitivi-ty, type of bridging research and pattern of bridging strategy were fre-quently involved.Conclusion Bridging study is being paid more atten-tion to, but we still need more data of clinical trial to conduct deep explo-ration.
