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Related Experiment Videos

A one-sided interim analysis with binary outcomes.

D R Bristol1

  • 1Development Department, CIBA-GEIGY Corporation, Summit, New Jersey 07901.

Controlled Clinical Trials
|September 1, 1988
PubMed
Summary
This summary is machine-generated.

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The analysis of failure time data in crossover studies.

Statistics in medicine·1992

This study introduces a generalized decision rule for clinical trials, enhancing early stopping criteria for treatment comparisons. The new method may improve the probability of stopping trials early when a treatment shows no benefit.

Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Medical Research Design

Background:

  • Existing methods for early trial termination exist for comparing response rates and means.
  • These methods allow stopping trials if a new treatment shows no improvement over a control.

Purpose of the Study:

  • To generalize a decision rule for clinical trials comparing two treatments.
  • To adapt a decision rule from mean comparisons to response rate comparisons in clinical trials.

Main Methods:

  • A generalized one-sided test decision rule is proposed for interim analysis.
  • The rule involves a one-sided test at the final analysis and an opposite-direction one-sided test at the interim analysis.

Main Results:

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  • The proposed generalization is applied to clinical trials comparing response rates.
  • The generalization may offer desirable properties for the probability of early trial termination.

    • Conclusions:

    • The generalized decision rule provides a flexible approach for early stopping in clinical trials.
    • This method enhances the efficiency of clinical trial design by allowing earlier cessation of ineffective treatments.