Testing for consistency in a single multicenter trial

Vernon Chinchilli, Enoch B. Bortey

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

One of the criteria for demonstrating efficacy in a single multicenter trial is that the centers are consistent with respect to the direction and significance of results. The purpose of this research is to discuss the use of the noncentrality parameter A of an F distribution as a means of testing for the consistency of treatment effects across centers. We state the testing problem as H0: {δ > δ0} versus H1: {A0}, where δ0is prespecified, so that H0represents inconsistency and H1consistency. Thus, strong evidence from the sample data is required in order to conclude that the treatment effects are consistent across centers, We discuss reasonable choices forδ0 and develop the a-level, uniformly most powerful and unbiased test, which is equivalent to rejecting H0if the 100(1 - a)% uniformly most accurate and unbiased upper confidence limit for A is less than or equal to δ0. We examine other tests based on upper confidence limits, such as those calculated from linear estimators of A and those calculated from a likelihood approach. We investigate the performance of the tests in a small simulation study and present an example from a four-center clinical trial.

Original languageEnglish (US)
Pages (from-to)67-80
Number of pages14
JournalJournal of Biopharmaceutical Statistics
Volume1
Issue number1
DOIs
StatePublished - Jan 1 1991

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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