title: Randomized n-of-1 Trials: Quality Improvement, Research, or Both?
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.
authors.affiliation: McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas;
authors.forename: Joyce P
authors.initials: JP
authors.lastname: Samuel
authors.affiliation: Center for Bioethics, Stanford University, Palo Alto, California; and.
authors.forename: Alyssa
authors.initials: A
authors.lastname: Burgart
authors.affiliation: McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas;
authors.forename: Susan H
authors.initials: SH
authors.lastname: Wootton
authors.affiliation: Center for Bioethics, Stanford University, Palo Alto, California; and.
authors.forename: David
authors.initials: D
authors.lastname: Magnus
authors.affiliation: Bioethics Center, Children's Mercy Hospital, Kansas City, Missouri jlantos@cmh.edu.
authors.forename: John D
authors.initials: JD
authors.lastname: Lantos
authors.affiliation: McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas;
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D002648:Child; D028744:Ethics Committees, Research; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D058996:Quality Improvement; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards*
chemical_list: D000959:Antihypertensive Agents