An introduction to the fundamentals of randomized controlled trials in pharmacy research.

The randomized controlled trial (RCT) is regarded as one of the most valued research methodologies for examining the efficacy or effectiveness of interventions.1 Randomized trials are most often associated with studies of drug effectiveness; however, they have also been successfully applied to research questions related to provision of care by pharmacists.2-5 This article is not intended to be an exhaustive guide on performing an RCT, but rather an introduction to the major concepts and approaches involved in designing and conducting an RCT. Readers requiring additional information are referred to more comprehensive publications6-9 and are encouraged to consult with researchers experienced in this area before undertaking a study. Throughout this paper, individuals enrolled in a study are referred to as “patients”, the individuals delivering the study (e.g., pharmacists in practice research) are referred to as the “investigators”, and those responsible for study design and analysis are referred to as the “study team”. DESIGN OF A RANDOMIZED CONTROLLED TRIAL