An analysis of the controversy over classical one-sided tests
- PMID: 19029216
- DOI: 10.1177/1740774508098590
An analysis of the controversy over classical one-sided tests
Erratum in
- Clin Trials. 2009 Apr;6(2):198
Abstract
Background: When applying classical tests of the null hypothesis in clinical trials, there has been considerable controversy over the choice between a one-sided versus a two-sided test. The choice between a one-sided and two-sided test still impacts on sample size calculations, assessment of study results by regulatory authorities, and publication of study results in academic journals.
Purpose: To analyze the main elements in the controversy, and examine the procedures from both a Bayesian and classical viewpoint.
Methods and results: Using a Bayesian decision framework, it is shown that there is no reason to double the p-value when moving from a one-sided to a two-sided test. Within the classical framework, it is shown that the doubling of the p-value results from a discontinuity due to testing a point null hypothesis. A three-decision rule, credited to Neyman or Wald, is presented that does not require the doubling of the p-value, and is consistent with a Bayesian approach.
Conclusions: For most comparative clinical trials the three-decision rule is appropriate, and its use would abolish the controversy over one-sided tests.
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