title: The clinical significance of statistical significance.
abstract: 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.
authors.affiliation: Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA. Robert.kane@fda.hhs.gov
authors.forename: Robert C
authors.initials: RC
authors.lastname: Kane
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D023381:Endpoint Determination; D005189:False Positive Reactions; D006801:Humans; D016016:Proportional Hazards Models; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic