Sample Size Adjustment in Clinical Trials for Proving Equivalence

Drug information journal : DIJ / Drug Information Association volume 35, pages1401–1408(2001)Cite this article

Abstract

To overcome the problem of uncertainty in the planning phase of clinical trials, study designs have been proposed that allow for mid-course reestimation of the sample size. Using a study in asthma patients, we illustrate how blind sample size adjustment can be performed in an equivalence trial. Thereby, we demonstrate how the type I error rate can be controlled. Further, we show that the well-known expectation-maximization algorithm-based procedure by Gould and Shih is inappropriate for the purpose of sample size reestimation.

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Author information

Affiliations

  1. Research Associate, Department of Mathematics and Statistics, Medical Statistics Unit, Lancaster University, Lancaster, UK

    Tim Friede PhD

  2. Head Biometrics, Department of Biometry, Dr. Willmar Schwabe Pharmaceuticals, Willmar-Schwabe-Straße 4, D-76227, Karlsruhe, Germany

    Dr. Meinhard Kieser PhD

Authors
  1. Tim Friede PhD
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  2. Dr. Meinhard Kieser PhD
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Correspondence to Dr. Meinhard Kieser PhD.

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Friede, T., Kieser, M. Sample Size Adjustment in Clinical Trials for Proving Equivalence. Ther Innov Regul Sci 35, 1401–1408 (2001). https://doi.org/10.1177/009286150103500436

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Key Words

  • Interim analysis
  • Sample size review
  • Sample size adjustment
  • Equivalence trial
  • Control of the type I error rate