title: The ethics of randomized clinical trials.
abstract: Randomized clinical trials pose a number of fundamental ethical problems to which morally sensitive investigators must give careful consideration. The randomized double-blind clinical trial is ethically justified and the preferred method of demonstrating therapeutic effectiveness and safety. Alternate methods such as crossover and self-controlled designs, the use of historical controls, observational methods, and practitioner's clinical trials also exist and have their place in certain circumstances. The use of randomized double-blind clinical trials must assure adequate explanation of the research plan to the patient, the documentation of informed consent, adequate consideration of safety, and an acceptably low risk/benefit ratio.
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000600:supply & distribution; D035061:Control Groups; D030881:Disclosure; D004311:Double-Blind Method; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D010919:Placebos; D011897:Random Allocation; D012107:Research Design; D035842:Research Subjects; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation
chemical_list: D010919:Placebos