中医药治疗肺癌临床研究的质量控制

随着循证医学理论在临床研究中的不断应用,中医药治疗肺癌的临床研究正在临床中积极开展。大样本多中心中医药治疗肺癌临床研究具有协作单位多、样本量大、观察及随访的周期长、方法学要求高等特点,因此临床质量控制就显得尤为重要。文章就中医药治疗肺癌临床研究质量控制的要求、内容及程序并结合广安门医院肿瘤科国家十一五科技支撑计划实际工作进行相关探讨,希望能对临床研究的质量提高有所裨益。

Control of Quality of Clinical Research in Treating Lung Cancer by Traditional Chinese Medicine

With the application of the theory of evidence-based medicine in clinical research,the clinical research in treating lung cancer by Traditional Chinese Medicine is being actively carried out.Clinical study of Large sample and multi-center in Traditional Chinese Medicine treatment of lung cancer has many Characteristics,such as many collaboration units,large sample volume,long life cycle of observation and follow-up,high level of methodologies demand and so on.So the clinical control of quality becomes particularly important.This paper gives many discussions about quality control requirements,content and procedures of treatment of lung cancer by Traditional Chinese Medicine in clinical research and about the actual work on National Eleventh Five-Year Plan of tumour department of Guang An Men Hospital.And hoping to improve the quality of clinical studies.