药物研发试验中存在的问题和改进之道

Problems and Improvements of Drug Research and Development

目前,药物研发过程中存在的某些问题,包括动物实验和Ⅰ期、Ⅱ期、Ⅲ期临床试验,乃至上市后药物试验中存在的问题,例如,对于动物实验与人体研究的巨大区别重视不够、动物实验方法过于简单、Ⅰ期和Ⅱ期临床研究过程过于理想化、试验与真实世界有较大差距,试验药品上市后研究缺乏严格地管控等,以上种种需要今后不断完善。伴随诊断自主研发市场尚处于空白阶段,我国应当尽快起草相应的指导性文件,规范药物的研发和应用,从而使各种药物的治疗方案更有效和更安全。

This paper briefly describes some problems existing in the process of drug research and development, including animal experiments, phaseⅠ, phaseⅡ and phase Ⅲ clinical trials, and even post-marketing clinical trials. It has not been attached enough importance to the great difference between animal experiments and human researches, the method of animal experiments is too simple, the clinical research process of phase Ⅰ and phase Ⅱ is too idealized, and there is also a big gap between clinical trial and the real world, and the post-marketing trial is lack of strict control, all of which need to be improved in the future. With the diagnosis of independent research and development market is still in a blank stage, China should draft the corresponding guidance policy as soon as possible to standardize the development and application of drugs, so as to make the treatment of various drugs more effective and safer.