对药物临床试验研究的文献计量学分析

目的了解国内药物临床试验研究发展动态,为今后的研究提供参考依据。方法通过中国知网的中国学术期刊网络出版总库数据,回顾2003年至2012年间国内药物临床试验研究的文献资料,用计量分析方法进行综合分析。结果 2003年至2012年间发表药物临床试验相关论文1418篇(平均每年141篇)。发表论文最多的单位为国家食品药品监督管理局药品评审中心(43篇)。相关学科的分布中药学最多(626篇),其中中国临床药理学杂志发表72篇。84篇论文得到国家、省、市级以及海外的共21种基金资助,占论文总数的6%。结论国内对药物临床试验研究的文献为持续增加的趋势,建议改善药物临床试验及其机构的质量管理、监管体制是文献中较为关注的内容。

Bibliometric Analysis of Good Clinical Practice

Objective Investigate the research situation and provide a reference for future research. Method According to Chinese academic journals-text of Chinese Hownet databases, we reviewed 10 years of good clinical practice （GCP） literature from 2003 to 2012 by quantitative analysis method. Result From 2003 to 2012 clinical trials were published 1418 papers （annual average 141papers）. Most papers published in units of the State Food and Drug Administration Drug Evaluation Center （43papers）. Distribution of pharmaceutical papers dominated maximum （626）, of which China Journal of Clinical Pharmacology published 72. 84 papers funded by national, provincial, municipal or overseas from a total of 21 kinds of funds, accounting for 6%of total number of papers. Conclusion Bibliometric analysis showed the clinical trial reports of the drug in our country are continuing in upward trend, and suggested more quality management of good clinical practice （GCP） and its institutions. The regulatory regime is more concerned in the content of the literature.