中药新药临床专业审评与临床研究现状的思考与探索

Consideration and Exploration of Present Situation in Clinical Specialized Assessment and study of New Chinese Medicines

中药新药技术审评不但要注意到处方与方解的合理性,更应注意到以实践作为主要根据。重视新药临床前的疗效评估,避免新药开发中的低水平重复,开发出疗效确切且安全的新药,造福人类,利国利民。申办单位在开发一种新药时,要注意是否符合中医辨证,更应注意到是否能达到预想的疗效。在新药临床研究过程中,要克服临床研究试验中的偏倚。为确保临床研究高质量地完成,监察员应由具有专业知识、素质高、事业心强的人员担当。

In the technical examination and assessment of new Chinese medicines attention should be paid to their prescriptions and the rationality of their explanation, much more to taking practice as their main basis. Importance should be attached to the assessment of the effectiveness of new medicines before they are used to clinical treament and the phenomenon of repitition at a low level in the development of new Chinese medicines should be ruled out so as to turn out new medicines with definite effectiveness and safety, thus bringing benefit to the nation and people and to the mankind. While applying for the development of a new medicine, the applicant institution should notice whether the new medicine to be developed accords with the dialectics of traditional Chinese medicine and it is able to achieve its predicted effectiveness in particular. In the process of clinical study and experiments of a new medicine any bias ideas and actions should be over-come. To guarantee the accomplishment of clinical studies at a high level, inspectors should be those who have specialized knowledge involved, high personal quality and a strong enterprising spirit.