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p-value and power computations in multiple look trials.

K E Peace, R C Schriver

    Journal of Chronic Diseases
    |January 1, 1987
    PubMed
    Summary
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    This study details p-values and power calculations for clinical trials with interim analyses. It proposes a new p-value definition consistent with group sequential methods, reflecting data strength against the null hypothesis.

    Area of Science:

    • Clinical Trials Methodology
    • Biostatistics
    • Statistical Inference

    Background:

    • Interim analyses in clinical trials allow for early assessment of accumulating data.
    • Group sequential methods are commonly used to manage early stopping or continuation decisions.
    • Accurate calculation of p-values and statistical power is crucial for trial integrity.

    Purpose of the Study:

    • To provide a detailed instructional guide on the design, decision-making, and computational aspects of p-values and power in clinical trials with planned interim analyses.
    • To propose a novel definition of the p-value specifically tailored for trials employing group sequential methods.
    • To ensure the proposed p-value definition aligns intuitively with the concept used in fixed sample size trials.

    Main Methods:

    Related Experiment Videos

  • The paper presents background theory and practical applications related to p-value and power calculations.
  • It introduces a new definition for p-values in the context of interim looks.
  • The methodology focuses on group sequential methods for clinical trial design.

    • Main Results:

    • The study offers detailed computational and design aspects for p-values and power in trials with interim analyses.
    • A new definition of the p-value is proposed, maintaining consistency with fixed sample size trial interpretations.
    • The proposed p-value reflects the conditional nature of data at each interim look.

    Conclusions:

    • The presented methods and p-value definition are suitable for clinical trials incorporating planned interim analyses.
    • The proposed p-value definition intuitively represents the strength of evidence against the null hypothesis.
    • This work enhances the statistical rigor of group sequential clinical trials.