A Reconsideration of Small Sample Studies and Absence of Equipoise as Ethical Issues in Research.

Abstract

In studies such as randomized controlled trials (RCTs), ethical requirements, inter alia, are that the study should be powered to detect the smallest clinically significant difference between treatments, and that the treatment groups should be in equipoise at the start of the trial. This article provides examples of circumstances where small sample, potentially underpowered studies may be justifiable, and where RCTs of treatments that are not in equipoise may be considered appropriate. The concepts presented may be extendable from RCTs to other study designs, as well.