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Further results on a multiple-testing procedure for clinical trials

D Seigel, R C Milton

    Biometrics
    |December 1, 1983
    PubMed

    Insights

    The O'Brien and Fleming procedure for multiple testing in clinical trials is effective for chronic diseases. While type I errors and power remain unchanged, sample size savings are reduced compared to acute disease models.

    Area of Science:

    • Clinical Trials
    • Biostatistics
    • Medical Research

    Background:

    • The O'Brien and Fleming procedure is a standard for multiple testing in acute disease clinical trials.
    • Evaluating its applicability to chronic disease models is crucial for optimizing trial design.

    Purpose of the Study:

    • To assess the O'Brien and Fleming procedure's efficacy and impact on sample size in chronic disease clinical trials.
    • To compare its performance against single-sample procedures.

    Main Methods:

    • The study evaluated the O'Brien and Fleming procedure using chronic-disease models.
    • Statistical analysis focused on type I error rates, statistical power, and sample size requirements.

    Main Results:

    • The O'Brien and Fleming procedure is applicable to chronic disease models without modification.
    • Type I errors and statistical power are comparable to single-sample procedures.
    • Sample size savings are less pronounced for chronic diseases than for acute diseases.

    Conclusions:

    • The O'Brien and Fleming procedure is a valid statistical method for multiple testing in chronic disease clinical trials.
    • Sample size reduction can be predicted based on power and the number of data inspections for specific disease models.

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