Randomized n-of-1 Trials: Quality Improvement, Research, or Both?
Where this comes from
- Record sourced from PubMed, PMID 27385811.
- Also identified by DOI 10.1542/peds.2016-1103 and PMC identifier 4960733.
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Abstract
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.
Medical subject headings
- Antihypertensive Agents
- Biomedical Research
- Hypertension
- Quality Improvement
- Randomized Controlled Trials as Topic