中药临床研究应用加载设计常见问题及注意事项

Frequent questions and attentions of applying add-on design to clinical study of Chinese medicine

加载设计指的是在使用安慰剂的对照试验中,设计方案为所有受试者在接受标准疗法的基础上,试验组加用试验药物,对照组加用模拟试验药的安慰剂。中药临床研究近年来加载设计应用较多,应该明确使用该设计的目的、常见的问题和注意事项。

An add-on design used in a place- bo-controlled clinical trial study, means desig- ning for all the subjects to receive a tested drug or placebo in addition to standard therapy. In re- cent years, since more add-on studies have been initiated {or clinical trials of Chinese medicine, itis necessary to make the objective, frequent questions and attentions more clearer.