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Flexible Interim Analyses in Clinical Trials Using Multistage Adaptive Test Designs

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Abstract

Data-dependent interim analyses are a useful tool in confirmatory Phase III or IV clinical research. In particular, redesigning the sample size in an interim analysis based on the results observed to date considerably improves the power of the trial since the best available information at the time is used for the sample size adjustment. In recent years, several methods were proposed that enable a flexible design through the use of adaptive interim analyses while maintaining the type I error rate. In this article, these methods are briefly reviewed. We recommend a strategy that copes well with the demands of practice. Examples illustrate the use of multistage adaptive designs that make it possible to calculate confidence intervals and bias adjusted point estimates.

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Authors and Affiliations

  1. Institut für Medizinische Statistik, Informatik und Epidemiologie, Universität zu Köln, Joseph-Stelzmann-Str. 9, D-50931 zu, Köln, Germany

    Gernot Wassmer PhD (Research Assistant) & Silke Coburger MSc (Research Assistant)

  2. ClinResearch GmbH, Cologne, Germany

    Reinhard Eisebitt MSc (Head)

Authors
  1. Gernot Wassmer PhD
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  2. Reinhard Eisebitt MSc
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  3. Silke Coburger MSc
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Correspondence to Gernot Wassmer PhD.

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Wassmer, G., Eisebitt, R. & Coburger, S. Flexible Interim Analyses in Clinical Trials Using Multistage Adaptive Test Designs. Ther Innov Regul Sci 35, 1131–1146 (2001). https://doi.org/10.1177/009286150103500410

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