Clinical Trials in Psychiatry

Abstract

Clinical trials were introduced as a method of scientific investigation before 1945 (Bull, 1959) and have been used extensively since, but it is only recently that publications devoted entirely to their management (design, conduct and analysis) have appeared (Controlled Clinical Trials, 1980; Friedman et al. 1981; Harris & Fitzgerald, 1970; Johnson & Johnson, 1977; Schwartz et al. 1980). Indeed, the methodology of clinical trials has developed to such an extent that their management is now highly complex (Peterson & Fisher, 1980), and the number of criteria to be satisfied in their design is formidable (Chalmers et al. 1981; Gore, 1982). In psychiatry many clinical trials conducted during the past twenty years have incorporated such important features of design as the inclusion of adequate controls, random and blind allocation of treatments, and blind assessment of ‘objective’ response. This editorial considers other equally important, though neglected, aspects of the design of clinical trials in psychiatry and re-emphasizes some notable aspects of their conduct and analysis. © 1983, Cambridge University Press. All rights reserved.