关于当前我国新药临床试验质量问题的思考

Thoughts on the quality of clinical trial of new drugs in China

新药研发一般要经历实验室化合物筛选、基础动物毒理药理研究、临床试验阶段,以及上市后再评价临床研究等环节。临床试验是决定新药能否上市的关键环节,而质量是新药临床试验的核心与灵魂,笔者就当前我国新药临床试验质量问题谈几点思考并提出建议。

It is well known that the development of new drugs is a systematic work with a long period of time.It is generally subject to laboratory compound screening,basic animal toxicology and pharmacology research,clinical trials,and post-marketing reevaluation of clinical research.Clinical trials are the key link in determining whether a new drug can be marketed.The quality is the core and soul of clinical trials of new drugs.This paper puts forward some thoughts and suggestions on the quality of clinical trials of new drugs in China.