Controlling for Multiplicity, Eligibility, and Exclusions
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.
KeywordsMultiple comparison procedures Inclusion/exclusion criteria Enrichment strategies
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