Randomized n-of-1 Trials: Quality Improvement, Research, or Both?

被引：6

作者：

Samuel, Joyce P. ^{[1
]}

Burgart, Alyssa ^{[2
]}

Wootton, Susan H. ^{[1
]}

Magnus, David ^{[2
]}

Lantos, John D. ^{[3
]}

Tyson, Jon E. ^{[1
]}

机构：

[1] Univ Texas Hlth Sci Ctr Houston, McGovern Med Sch, Houston, TX 77030 USA

[2] Stanford Univ, Ctr Bioeth, Palo Alto, CA 94304 USA

[3] Childrens Mercy Hosp, Bioeth Ctr, Kansas City, MO 64108 USA

来源：

PEDIATRICS | 2016年 / 138卷 / 02期

基金：

美国国家卫生研究院;

关键词：

PATIENT SAFETY; ETHICS;

D O I：

10.1542/peds.2016-1103

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

The regulatory demarcations between clinical research and quality improvement (QI) are ambiguous and controversial. Some projects that were undertaken as a form of QI were deemed by regulatory agencies to be research and thus to require institutional review board approval. In the era of personalized medicine, some physicians may ask some patients to participate in n-of-1 trials in an effort to personalize and optimize each patient's medical treatment. Should such activities be considered research, QI, or just excellent personalized medicine? Experts in research, research regulation, and bioethics analyze these issues.

引用

页数：5

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