论文部分内容阅读
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。
With the continuous application of evidence-based medical theory in clinical research, the clinical research of Chinese medicine in the treatment of lung cancer is being actively carried out in clinical practice. Large sample multi-center Chinese medicine treatment of lung cancer clinical research with collaborative units, a large sample size, observation and follow-up of the long cycle, higher methodological requirements, so clinical quality control is particularly important. The article discusses the requirements, contents and procedures of TCM quality control of lung cancer clinical research, combined with the practical work of Guang’anmen Hospital National Eleventh Five-Year Science and Technology Support Program, hoping to improve the quality of clinical research.