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Related Experiment Videos

One-sided and two-sided tests and p values.

G G Koch1

  • 1Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill 27599-7400.

Journal of Biopharmaceutical Statistics
|January 1, 1991
PubMed
Summary
This summary is machine-generated.

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This study discusses one-sided vs. two-sided statistical tests, recommending clear documentation and specific reporting for biopharmaceutical studies. Two-sided tests are generally preferred for academic research due to their handling of potential findings in either direction.

Area of Science:

  • Biostatistics
  • Clinical Trial Design

Background:

  • Statistical testing involves choosing between one-sided and two-sided approaches.
  • The choice impacts study design, conclusion stringency, and result interpretation.

Purpose of the Study:

  • To provide guidance on selecting and applying one-sided and two-sided statistical tests.
  • To outline best practices for confirmatory biopharmaceutical studies and academic research.

Main Methods:

  • Discussion of inferential posture, stringency levels, p-value reporting, and confidence intervals.
  • Recommendations for documenting study objectives and sample size considerations.

Main Results:

  • For confirmatory biopharmaceutical studies, clear protocol documentation of one-sided objectives is crucial.

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  • Sufficient sample size, one-sided p-values with flags, and one-sided confidence intervals are recommended for specific inferences.
  • Opposite direction results should be interpreted descriptively, not inferentially.

    • Conclusions:

    • Two-sided tests are generally more suitable for academic studies due to their inherent adjustment for multiplicity.
    • Appropriate use of one-sided tests requires careful consideration of study design and inferential goals.