title: Clinical trials.
abstract: Broad guidelines for the design, implementation, analysis, and reporting of results of clinical trials are given. The use of randomization, concurrent controls, and blinding is justified. Basic principles of the design of clinical trials are outlined and include the areas of specification of the hypothesis, definition of the outcome and the logistics of protocol design, and safeguards to ensure its proper implementation.
authors.affiliation: Biometry and Field Studies Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.
authors.forename: J H
authors.initials: JH
authors.lastname: Ellenberg
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D006801:Humans; D011897:Random Allocation