Controlling for Multiplicity, Eligibility, and Exclusions

Amber Albright, J. Philip Miller

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


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.

Original languageEnglish
Title of host publicationPrinciples and Practice of Clinical Trials
PublisherSpringer International Publishing
Number of pages9
ISBN (Electronic)9783319526362
ISBN (Print)9783319526355
StatePublished - Jan 1 2022


  • Enrichment strategies
  • Inclusion/exclusion criteria
  • Multiple comparison procedures


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