Abstract

The estimation of the correct sample size to successfully test a hypothesis has become critical. A common approach to this problem is for the investigating team to complete a pilot study of a few patients to establish the "active drug-placebo" difference, using this "effect size" to perform the power analysis for sample size estimation. Given the variability evident in the effect size from completed and published studies, the pilot study approach may not be entirely dependable. The authors propose a method to obtain this initial "active drug-placebo" difference, in the field of psychotropic drug research. They apply meta-analysis to statistically summarize effect sizes obtained from an exhaustive review of the literature for a specific psychotropic drug in a given clinical condition. All double-blind, random assignment studies are used to calculate the effect size; therefore, no selection bias exists. These literature-based effect sizes are then used to perform the traditional power analysis for sample size estimation. The authors propose these estimations as a convenient reference source for future clinical investigators.