作　　者： (沈宁）; (胡良平）;

机构地区： 军事医学科学院生物医学统计学咨询中心,北京100850

出　　处： 《四川精神卫生》 2017年第4期306-309,共4页

摘　　要： 本文目的是以提纲挈领的形式呈现临床试验设计之要览。首先,扼要介绍了临床研究类型和临床试验设计类型。第二,介绍了新药临床试验研究的分期和比较类型。第三,重点阐释了新药临床试验设计的核心内容,即(1)严格遵守临床试验研究方面的法律、法规、规范、原则和指南;(2)严格遵守医学伦理道德;(3)严格把握临床试验的"三要素";(4)严格遵循临床试验的"四原则";(5)合理选定临床试验"设计类型";(6)合理选定临床试验"比较类型";(7)制订并落实"标准操作规程";(8)制订并落实"质量控制策略"。 The object of this article is to briefly summarize the core concepts of design of clinical trials design. First of all, we concisely introduce the concept and difference between the research type and design type for clinical trials. Secondly, we introduce the phases of clinical trials involving new drug, and the difference between the superiority, equivalence, and non - inferiority trials which is named “ Comparative type”. At last, we focus on elaborating the key points in designing of a new drug clinical trial, and thus summarizing the main points as follows： （l）Complying strictly with institutional, national, or international guidelines. （2）In accordance with the ethical policies.③In adherence to the “Three essence” during designing of a trial.④In adherence to the “Four Principles” during designing of a trial. ？Properly choosing an accurate design type for a clinical trial. ？Properly choosing a comparative type for a clinical trial.⑦Formulate and implement the “tandard operating procedures”⑧Formulate and implement the“uality control strategy”.

关 键 词： 临床试验 试验设计 设计类型 比较类型 标准操作规程 质量控制