小儿积滞中药临床试验设计与评价技术指南

Guideline on design and evaluation of clinical trials for Chinese medicine in common pediatric diseases:Food accumulation and stagnation in children

《小儿积滞中药临床试验设计与评价技术指南》为中华中医药学会标准化项目《儿科系列常见病中药临床试验设计与评价技术指南》之一。其目的是以临床价值为导向,主要是在中医病证研究模式下,重点讨论具有病种、儿童和中药特点的临床定位、试验设计与实施等相关问题,为中药治疗小儿积滞临床试验设计与评价提供思路和方法。制定过程中先后成立指南工作组、起草专家组和定稿专家组,采用文献研究和共识会议的方法,最终形成指南送审稿定稿。该指南的主要内容包括临床定位、试验总体设计、诊断标准与辨证标准、受试者的选择与退出、治疗方案、有效性评价、安全性观察、试验流程、试验的质量控制9部分,以期为申办者或合同研究组织、研究者在小儿积滞中药临床试验及上市后临床有效性再评价方案设计中提供借鉴与参考。

Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases:Food Accumulation and Stagnation in children is one of the standardization projects of the China Association of Traditional Chinese Medicine Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases.The purpose is to discuss the clinical positioning,experimental design and implementation of the characteristics of diseases,children and traditional Chinese medicine under the mode of combining disease and syndrome with clinical value,so as to provide suggestions and methods for the design and evaluation of clinical trial of food accumulation and stagnation in children with traditional Chinese medicine.In the process of developing,working group on the guidelines,drafter group and a finalizer group were established,and the methods of literature research and consensus meeting were adopted to form the final draft of the guidelines.The main contents of this guideline include clinical positioning,overall design of the trial,diagnostic and syndrome differentiation criteria,selection and withdrawal of subjects,administration scheme,effectiveness evaluation,safety observation,trial process,quality control of the trial.The formulation of this guideline provides references for the sponsor or contract research organizations and researchers to design clinical trials and post-marketing evaluation on the treatment of food accumulation and stagnation in children with traditional Chinese medicine.