单病例随机对照试验相关伦理问题探析

Preliminary Exploration on Ethical Issues Related to Randomized Controlled Trial in Individual Patient Clinical Trial

目的：对单病例随机对照试验（N-of-1）在临床试验过程中的伦理审查现状进行分析研究。方法：查阅国内外相关文献和最新版指南,对临床试验的伦理审查进行分析,运用比较研究法讨论单病例随机对照试验相关伦理问题。结果：单病例随机对照试验伦理审查的重要性不容忽视,但目前临床上N-of-1的伦理审查阶段仍较为模糊。结论：单病例随机对照试验作为一种新兴的临床试验设计方法,其伦理审查还需进一步明确与规范。

Objective： To analyze the current situation of ethical examination in the randomized controlled trial in individual patient（ N-of-1） in clinical trial. Method： The author referred to the relevant literature both at home and aborad and then compared the ethical review of clinical trials and gave a thorough analysis and used the comparative study to discuss the ethical issues related to the N-of-1. Results： Ethical review of N-of-1 is very important in the real remedy,but the current criteria of ethical review of N-of-1 is still vague. Conclusion： At present,N-of-1 is well-developed by the experts. However,as a new clinical trial,N-of-1 needs to be clarified further and regulated in ethical review.