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

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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.

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Authors and Affiliations

  1. Medical Statistics Group, Health Services Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England

    Steven A. Julious

  2. Office of Biostatistics, Office of Translationat Sciences, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA

    Sue-Jane Wang

Authors
  1. Steven A. Julious
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  2. Sue-Jane Wang
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Correspondence to Steven A. Julious.

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The views expressed in this article are the professional views of the author and do not necessarily reflect the official position of the US food and Drug Administration.

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Julious, S.A., Wang, SJ. How Biased Are Indirect Comparisons, Particularly When Comparisons Are Made Over Time in Controlled Trials?. Ther Innov Regul Sci 42, 625–633 (2008). https://doi.org/10.1177/009286150804200610

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  • DOI: https://doi.org/10.1177/009286150804200610

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