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Controlling for Multiplicity, Eligibility, and Exclusions

In: Principles and Practice of Clinical Trials

Author

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  • Amber Salter

    (Washington University School of Medicine in St. Louis, Division of Biostatistics)

  • J. Philip Miller

    (Washington University School of Medicine in St. Louis, Division of Biostatistics)

Abstract

Multiple comparison procedures play an important role in controlling the accuracy of clinical trial results while trial eligibility and exclusions have the potential to introduce bias and reduce external validity. This chapter introduces the issues and sources of multiplicity and provides a description of the many different procedures that can be used to address multiplicity primarily used in the confirmatory clinical trial setting. Additionally, trial inclusion/exclusion criteria and enrichment strategies are reviewed.

Suggested Citation

  • Amber Salter & J. Philip Miller, 2022. "Controlling for Multiplicity, Eligibility, and Exclusions," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 39, pages 729-737, Springer.
  • Handle: RePEc:spr:sprchp:978-3-319-52636-2_210
    DOI: 10.1007/978-3-319-52636-2_210
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