中药新药防治儿童注意缺陷-多动障碍临床研究设计与评价要点

Key Points for Design and Evaluation of Clinical Studies in Treating Children's Attention Deficit Hyperactivity Disorder by Chinese Medical New Drugs

在收集国内外资料的基础上,结合临床科研实践,在试验目的与设计、诊断标准选择、受试者的入选与退出、有效性评价、安全性评价、合并用药及质量控制等方面,总结了中药新药防治儿童注意缺陷-多动障碍临床研究技术要点,以期为本病的中药新药临床试验设计提供借鉴。

Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children＇s attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.