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An examination of the relative impact of type i and type II error rates in phase II drug screening trial queues

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Abstract

In this note, we highlight the fact that the choice of type I and type II error rates should not simply be set at traditional levels in the phase II clinical trial setting when considering the relative success rate of previous trials in a given disease setting. For diseases in which it is rare that a new compound is active, we argue that more stringent type I error rates in the phase II setting may be more important relative to relaxing the type II error rates. The paper itself is more of a 'thought' experiment on this topic such that specific clinical trial settings will require specific applications of this approach. This is due in part to the fact that the real-world setting is more complex relative to overall decision process in terms of moving from phase II to phase III trials than our basic illustrative model.

Original languageEnglish
Pages (from-to)157-162
Number of pages6
JournalPharmaceutical Statistics
Volume11
Issue number2
DOIs
StatePublished - Mar 2012

Keywords

  • clinical trial design
  • cost-effectiveness

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