中国临床药理学与治疗学2011，Vol.16Issue(5)：586-589,4.
基于有效性及伦理学原则探讨新药Ⅱ、Ⅲ期临床试验的设计思路与方法
Design idea and methodology for the II and III clinical trial of the new drugs in view of effectiveness and ethics
摘要
Abstract
For clinical trials, efficacy evaluation of new drugs might not be reliable if it is based on positive drugs for comparison. Furthermore, the clinical trial itself might encounter general ethical problems. When proposing clinical trials for new drugs, placebo drugs should be chosen for comparison during Phase Ⅱ. In view of research objective and disease situation, patients with mild conditions should be chosen for clinical trials. On the basis of effectiveness of the new drugs, second stage of Phase Ⅱ and Phase Ⅲ can be arranged. Add-on research methodology can be adopted in the second stage of Phase Ⅱ to adequately extend indication.Phase Ⅲ clinical trials can choose placebo or suitable positive drugs for comparison. This will ensure the effectiveness of the new drugs as well as meet the ethical requirements.关键词
疗效/伦理学/临床试验/设计Key words
Therapeutic effect/ Ethics/ Clinical trials/ Design分类
医药卫生引用本文复制引用
毕京峰,陈素红,魏振满..基于有效性及伦理学原则探讨新药Ⅱ、Ⅲ期临床试验的设计思路与方法[J].中国临床药理学与治疗学,2011,16(5):586-589,4.基金项目
国家科技重大专项课题(2009ZX10005- 017) （2009ZX10005- 017）
中国人民解放军第三○二医院院内课题(YNKT 2010012) （YNKT 2010012）
