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本文通过检索近年国内外公开发表的大量临床研究论文,对比分析同品种新药的人体药动学数据差异,探究文献数据异同的原因,剖析我国I期临床试验数据质量及可能存在的问题,并提出改进的合理化建议,以期为规范行业行为、提高国内临床研究质量、制订相关的监管政策提供帮助,同时也为研究者、申办者、监管部门及文献出版部门提供警示信息。
In this paper, by searching a large number of published clinical papers at home and abroad in recent years, the differences of human pharmacokinetic data of the same kind of new drugs are analyzed and compared. The reasons for the similarities and differences of the literature data are analyzed. The data quality and possible problems of Phase I clinical trials in China are analyzed. Improve the rationalization proposals, with a view to help regulate the industry behavior, improve the quality of clinical research in China, to develop relevant regulatory policies to help, but also for researchers, sponsors, regulators and documentary publishing department to provide warning messages.