title: Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases.
abstract: Placebo controls are commonly used in clinical trials of investigational treatments because they have important advantages. In recent years, some have criticized the use of placebo-controlled trials when effective alternative therapy exists, regardless of the expected effect of the therapy. In part 1 of this paper, ethical arguments are addressed and the interpretive problems inherent in the use of active-control equivalence trials to establish efficacy of a new treatment are clarified. However, uncertainties may complicate decisions about appropriate use of placebo controls in some situations. Part 2 discusses more fully the ethical considerations for using placebo controls in particular medical settings. The value and relevance of placebo-controlled trials of new agents in situations in which proven effective therapy is available are also explored.
authors.affiliation: Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: S S
authors.initials: SS
authors.lastname: Ellenberg
authors.forename: R
authors.initials: R
authors.lastname: Temple
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D003657:Decision Making; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D010919:Placebos; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D010919:Placebos