中药新药研发临床定位的相关思考

Consideration of clinical orientation in the research of new traditional Chinese medicine

临床定位是药品在拟定目标适应证中预期的治疗作用,临床定位准确是新药研发成功和上市后临床合理用药的关键。在中药新药临床定位时,需要从研究药物、目标疾病、已有治疗措施和审评要求等维度评估合理性。临床定位的方法与依据包括人用经验、中医药理论、基础研究和临床试验等。以临床价值为导向,选定合理的临床定位,才能真正体现中药的疗效,提高中药新药的研发质量和成功率。

Clinical orientation is the expected therapeutic effect of drugs on diseases,and accurate clinical orientation is the key to successful development of new drugs and clinical rational drug use after marketing.The rationality of clinical orientation for traditional Chinese medicine should be evaluated from the aspects of research drugs,targeting diseases,existing therapeutic drugs and review requirements.The methods and basis of clinical orientation include human experience,theory of traditional Chinese medicine,basic researches and clinical trials.By selecting reasonable clinical orientation and taking clinical value as the guidance,the curative effect of traditional Chinese medicine can be truly reflected,and the quality of research and development and success rate of new Chinese medicine will be improved.