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First Published Online November 4, 2008
The Oncologist, Vol. 13, No. 11, 1129-1133, November 2008; doi:10.1634/theoncologist.2008-0186
© 2008 AlphaMed Press

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Commentary

The Clinical Significance of Statistical Significance

Robert C. Kane

Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Key Words. Statistical significance • Alpha • False positive inference

Correspondence: Robert C. Kane, M.D., Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA. Telephone: 301-796-2330; Fax: 301-796-9845; e-mail: Robert.kane{at}fda.hhs.gov

Received August 22, 2008; accepted for publication September 23, 2008; first published online in THE ONCOLOGIST Express on November 4, 2008.

Disclosure: The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the author, planners, independent peer reviewers, or staff managers.

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.






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