中医药治疗感冒大样本多中心随机双盲对照试验的质量控制内容与方法

Content and Methods of Quality Control for a Large Sample,Multicenter,Randomized,Double-blind Controlled Trial of Chinese Medicine Treatment of Cold

由于受到受试者依从性差、合并药物的漏记等因素影响,中医药治疗感冒大样本、多中心、随机、双盲对照试验实施过程中质量控制难度大,从而影响研究结果的真实性和科学性。为保障研究实施质量,在抗病毒口服液治疗感冒的3000例多中心、随机、双盲对照试验中,采用了现场与远程交互的质量控制方法。现场质量控制优势在于面对面接触研究者(实施干预者、疗效评价者)和受试者,适宜开展研究相关人员访谈和研究信息溯源;远程质量控制优势在于实时性,质量控制人员通过远程质量控制实时了解研究进度、不良事件等情况,同时可以根据远程质量控制的评估结果调整现场质量控制的核查频率,在保障研究质量的同时节省质量控制成本的投入。此质量控制内容和方法较好地控制了研究实施的质量,可为中医药治疗感冒随机对照试验中实施的质量控制提供参考。

Because of the influence of subjects＇ poor compliance, failure to record the combined drugs and other factors, it is difficult to make quality control during the large sample multicenter, randomized, double-blind controlled trials of Chinese Medicine treatment of cold, which finally will affect the authenticity and scientific nature of the study results. To ensure research implementation quality, in a multicenter, randomized, double-blind controlled trial including 3000 cases of cold treated with antiviral oral liquid, the quality control method of field distance interaction was adopted. The advantage of field quality control was researchers （implementation interveners and effect evaluators） and subjects could meet face to face. Thus it was appropriate to develop interview of research related personnel and to study the information origins. The advantage of distance quality control was real-time. Quality control personnel could know study progress, adverse events and other situations by distance quality control instantly and meanwhile adjust check frequency of field quality control according to evaluation results of distance quality control, so that to save quality control cost, and at the same time ensure research quality. The content and methods of quality control did well control the quality of research, and it provided references for quality control in randomized controlled trials of Chinese Medicine treatment of cold.