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Curtailed binomial sampling procedures for clinical trials with paired data.

N Herrmann, T H Szatrowski

    Controlled Clinical Trials
    |March 1, 1985
    PubMed
    Summary

    Curtailed sampling procedures can significantly reduce sample sizes in clinical trials with paired data. These methods offer substantial savings compared to traditional fixed sample size tests, making them a valuable design consideration.

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    Area of Science:

    • Biostatistics
    • Clinical Trial Design
    • Statistical Methods

    Background:

    • Clinical trials with dichotomous responses and paired data often require large sample sizes.
    • Traditional fixed sample size designs may be inefficient.
    • Evaluating alternative sampling procedures is crucial for optimizing trial efficiency.

    Purpose of the Study:

    • To review the application of curtailed sampling procedures in clinical trial design.
    • To present methods for quantifying sample size savings.
    • To compare curtailed procedures with fixed and repeated significance testing.

    Main Methods:

    • Review of existing literature on curtailed sampling in clinical trials.
    • Development of tables for expected sample size savings.

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  • Derivation of a simple asymptotic formula for expected sample size savings.
  • Comparative analysis of fixed, curtailed, and repeated significance testing procedures.

    • Main Results:

    • Curtailed sampling procedures demonstrate substantial sample size savings under specific conditions.
    • A simple asymptotic formula accurately approximates expected sample size savings.
    • Comparisons highlight the efficiency of curtailed methods relative to fixed sample size tests.

    Conclusions:

    • Curtailed sampling procedures offer significant advantages in terms of sample size reduction for clinical trials.
    • The accuracy of the approximating formula supports the practical application of these methods.
    • Serious consideration of curtailed procedures in clinical trial design is recommended for improved efficiency.