The Clinical Significance of Statistical Significance

Abstract

Abstract Learning Objectives After completing this course, the reader should be able to: Explain the difference between exploratory (hypothesis-generating) analyses and confirmatory (hypothesis-testing) analyses.Describe why a statistical test result (p-value) only expresses the likelihood that the result could have occurred by chance and does not prove the truth of the study.Define what a hazard ratio expresses. CME This article is available for continuing medical education credit at CME.TheOncologist.com Modern clinical trials provide the evidence for most therapeutic advances, and that evidence, expressed in a statistical format, is used to draw inferences about a population from the study's results. Clinician judgment translates these inferences for best individual patient care, but many clinicians struggle with the statistical interpretation of trial results. This review provides a clinical and non-Bayesian perspective on some key elements in the statistical design, analysis, and interpretation of randomized, comparative, phase III clinical trials intended to demonstrate a better outcome (superiority) than with a control treatment.