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Improved Test Procedure and Sample Size Calculation for Assessing Similarity in Two-Group Comparative Studies with Heterogeneous Variances

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Listed:
  • Show-Li Jan

    (Chung Yuan Christian University)

  • Gwowen Shieh

    (National Yang Ming Chiao Tung University)

Abstract

The two one-sided tests (TOST) method for mean equivalence or average equivalence has been extended to assessing similarity or switchability for individual equivalence in clinical trials. Tolerance interval procedures are available to establish similarity with respect to the proportion of the response differences covered by a prespecified threshold range. However, the extended TOST procedures based on tolerance intervals are potentially susceptible to the control of Type I errors. This article aims to present an exact approach with the specified Type I error probability for appraising similarity between two treatments in comparative studies with heterogeneous variances. Analytic examination and numerical comparison are conducted to clarify the utility of the suggested similarity test and the drawback of the current TOST procedures. To enhance the usefulness of the described exact method, the related power and sample size issues are also considered. Computer algorithms are provided to implement the proposed test procedure, power calculation, and sample size determination in similarity studies.

Suggested Citation

  • Show-Li Jan & Gwowen Shieh, 2024. "Improved Test Procedure and Sample Size Calculation for Assessing Similarity in Two-Group Comparative Studies with Heterogeneous Variances," Sankhya B: The Indian Journal of Statistics, Springer;Indian Statistical Institute, vol. 86(2), pages 724-742, November.
    • Handle: RePEc:spr:sankhb:v:86:y:2024:i:2:d:10.1007_s13571-024-00334-y
    DOI: 10.1007/s13571-024-00334-y
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    References listed on IDEAS

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    1. Gwowen Shieh, 2016. "Exact Power and Sample Size Calculations for the Two One-Sided Tests of Equivalence," PLOS ONE, Public Library of Science, vol. 11(9), pages 1-9, September.
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