Sample Size for Clinical Trials

Abstract

The gold standard of study design in clinical investigation is the randomized controlled trial (RCT). Over the past 50 years, RCTs have come to be considered the primary source of evidence for the efficacy of newer therapeutic interventions (Matthews, 2006). The design of the trial varies with the phase of the clinical trial (I-IV) and is dependent on several statistical exercises. Typically, sample size calculation and statistical power are critical components of study design.

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