When regulatory requirements conflict with ethical study design: the case of oral ondansetron.
Markman
M
M
Cleveland Clinic Cancer Center, Ohio.
D000970:Antineoplastic Agents / Q000009:adverse effects; D035061:Control Groups; D004311:Double-Blind Method; D004335:Drug and Narcotic Control; D004992:Ethics, Medical; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D017294:Ondansetron / Q000627:therapeutic use*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D036302:Therapeutic Human Experimentation; D014481:United States; D014486:United States Food and Drug Administration; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control
D000970:Antineoplastic Agents; D010919:Placebos; D017294:Ondansetron