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Related Experiment Videos

The alternative hypothesis: one-sided or two-sided?

K E Peace1

  • 1Parke-Davis Research Division, Warner-Lambert Company, Ann Arbor, MI 48105.

Journal of Clinical Epidemiology
|January 1, 1989
PubMed
Summary
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For pharmaceutical clinical trials, a one-sided hypothesis test is more appropriate than a two-sided test. This approach should be standard for confirmatory efficacy studies.

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmaceutical Research

Background:

  • Traditional clinical trial design often employs two-sided hypothesis testing.
  • This approach may be less statistically powerful for demonstrating drug efficacy.
  • The use of one-sided hypothesis testing is not universally adopted in confirmatory trials.

Purpose of the Study:

  • To evaluate the appropriateness of one-sided alternative hypotheses in clinical trial settings.
  • To advocate for the adoption of one-sided hypothesis testing in confirmatory efficacy trials.
  • To provide examples illustrating the benefits of one-sided hypothesis testing.

Main Methods:

  • Discussion of statistical hypothesis testing frameworks.
  • Comparative analysis of one-sided versus two-sided alternative hypotheses.

Related Experiment Videos

  • Illustrative examples from pharmaceutical clinical trials.

    • Main Results:

    • One-sided hypothesis testing offers increased statistical power for detecting efficacy.
    • The choice of hypothesis testing framework impacts the interpretation of trial results.
    • Pharmaceutical confirmatory efficacy trials are well-suited for one-sided testing.

    Conclusions:

    • Confirmatory efficacy clinical trials for pharmaceutical compounds should consistently utilize a one-sided alternative hypothesis framework.
    • This approach enhances the ability to detect true treatment effects.
    • Adopting one-sided testing represents a more statistically rigorous methodology for efficacy confirmation.