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How Biased Are Indirect Comparisons, Particularly When Comparisons Are Made Over Time in Controlled Trials?

  • Steven A. JuliousEmail author
  • Sue-Jane Wang
Statistics

Abstract

Indirect comparisons are undertaken when a comparison is made between two regimens, usually where the regimens have never been given concurrently in any controlled trial investigating the same general patient population. We highlight the issues of making indirect comparisons when there has been a period of time between the studies, particularly when indirect comparison is being made to placebo. We discuss the impact of any bias in indirectly estimating any effect over placebo in context with noninferiority trials.

Key Words

Clinical trials Indirect comparisons Noninferiority Placebo creep 

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Copyright information

© Drug Information Association, Inc 2008

Authors and Affiliations

  1. 1.Medical Statistics Group, Health Services ResearchUniversity of SheffieldSheffieldEngland
  2. 2.Office of Biostatistics, Office of Translationat SciencesCenter for Drug Evaluation and Research, US FDASilver SpringUSA

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