Bibliometrics and visualization analysis of research papers on Ethical Review of drug clinical trials in China / 中华医学科研管理杂志

ABSTRACT

Objective:To better understand the development of domestic drug clinical trial ethical review related research, and provide possible reference for future studies.Methods:The data were searched and extracted from the databases such as CNKI, WANFANG. Research Papers on Ethical Review of drug clinical trials in China from 2003 to 2020 were reviewed. Bibliometric and visualization method was used to analyze the number of publications, journal categories, authors, key words, et al.Results:336 papers were selected according to the criteria. The number of published papers was increasing slowly during the years. These papers were published in 107 journals, authors from the Affiliated Hospital of Nanjing University of Chinese Medicine participated in the largest publications. Beijing, Jiangsu and Shanghai ranked among the top three in terms of papers published by medical and scientific research institutions. The largest numbers of such paper were published in Chinese Journal of Medical Ethics (53). The most collaborative authors were Xiong Ningning, Liu Haitao, Lu Qi, Wang Xiuqin, Wu Cuiyun. The research hotspots were human subject protection, post-approval management, multi-center clinical trials, pregnant participant, clinical trials involving children, Good Clinical Practice and COVID-19 in recent years. There were about 11 kinds of research funding from provincial level and higher. Conclusions:It is helpful for researchers to understand the knowledge structures, latest progress, seeking for cooperation and communication, improvement and paper submission in their fields of ethical review through bibliometrics and visualization analysis.