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Related Experiment Videos

Some thoughts on the one-sided and two-sided tests.

S D Dubey1

  • 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland.

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

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This study advocates for two-sided tests in clinical trials, offering regulatory and academic perspectives. While one-sided tests have specific uses, two-sided approaches are recommended for complex or controversial situations.

Area of Science:

  • Clinical Trials Methodology
  • Statistical Inference in Medicine
  • Regulatory Science

Background:

  • Clinical trials require robust statistical methods for drug approval.
  • The choice between one-sided and two-sided tests impacts trial interpretation and regulatory acceptance.
  • Current practices and academic views on hypothesis testing in drug development vary.

Purpose of the Study:

  • To explore scientific and regulatory perspectives on one-sided versus two-sided tests in clinical trials.
  • To provide insights into academic views and current practices.
  • To recommend appropriate testing strategies based on clinical trial context.

Main Methods:

  • Review of scientific literature and regulatory guidelines.
  • Analysis of academic viewpoints on statistical testing in clinical trials.

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  • Discussion of practical applications and case scenarios.

    • Main Results:

    • Two-sided tests are generally favored across a broad range of clinical trial scenarios.
    • Specific situations where one-sided tests may be justifiable are identified.
    • The paper highlights the importance of context in selecting the appropriate statistical test.

    Conclusions:

    • Two-sided tests offer a more comprehensive approach for most clinical trial evaluations.
    • The use of one-sided tests should be carefully considered and justified.
    • In ambiguous or controversial cases, two-sided tests are the recommended approach for enhanced scientific rigor and regulatory compliance.