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A multiple testing procedure for clinical trials.

P C O'Brien, T R Fleming

    Biometrics
    |September 1, 1979
    PubMed
    Summary
    This summary is machine-generated.

    This study introduces a new multiple testing procedure for immediate, dichotomous treatment outcomes. The method controls statistical error rates similarly to traditional tests while potentially resolving ethical issues in clinical trials by allowing early termination.

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    Area of Science:

    • Biostatistics
    • Clinical Trial Design
    • Statistical Inference

    Background:

    • Comparing two treatments with dichotomous outcomes is common in clinical trials.
    • Immediate responses simplify data collection but pose statistical challenges.
    • Ethical considerations often arise regarding trial duration and patient allocation.

    Purpose of the Study:

    • To propose a novel multiple testing procedure for comparing two treatments with immediate, dichotomous responses.
    • To ensure the overall statistical significance level (Type I error rate) is controlled.
    • To enhance ethical trial conduct by enabling early stopping.

    Main Methods:

    • A sequential multiple testing procedure is developed.
    • The Pearson chi-square statistic is used at each interim analysis.

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  • Pre-specified maximum number of tests (N) and observations between tests (m1 + m2) are fixed.
  • The procedure's Type I error rate and power are analyzed theoretically.

    • Main Results:

    • The proposed procedure effectively controls the overall Type I error rate, comparable to a single test on all data.
    • Statistical power remains virtually equivalent to a standard chi-square test.
    • Early termination is possible when one treatment shows a clear advantage.

    Conclusions:

    • The multiple testing procedure offers a statistically sound and ethically advantageous alternative for clinical trials with immediate, dichotomous outcomes.
    • It maintains the integrity of statistical testing while addressing practical and ethical concerns.
    • This method can lead to more efficient and responsible clinical research.