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Multiplicity Considerations in the Design and Analysis of Clinical Trials

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  • Richard J. Cook
  • Vern T. Farewell

Abstract

The need for efficient use of available resources in medical research has led to the increased appeal of clinical trial designs based on multiple responses, multiple treatment arms and repeated tests of significance. In recent years there has been considerable methodological work pertaining to these types of multiple comparison, with the common objective typically being the control of the experimental type I error rate. Here we reconsider the appropriateness of these objectives in a variety of contexts and suggest that multiple‐comparison procedures are frequently adopted unnecessarily. In particular we argue that, provided that a select number of important well‐defined clinical questions are specified at the design, there are situations in which multiple tests of significance can be performed without control of the experimental type I error rate. The primary restriction for this to be reasonable is that test results are interpreted marginally.

Suggested Citation

  • Richard J. Cook & Vern T. Farewell, 1996. "Multiplicity Considerations in the Design and Analysis of Clinical Trials," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 159(1), pages 93-110, January.
    • Handle: RePEc:bla:jorssa:v:159:y:1996:i:1:p:93-110
    DOI: 10.2307/2983471
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    Cited by:

    1. Peter Z. Schochet, 2009. "An Approach for Addressing the Multiple Testing Problem in Social Policy Impact Evaluations," Evaluation Review, , vol. 33(6), pages 539-567, December.
    2. David Albouy, 2013. "Partisan Representation in Congress and the Geographic Distribution of Federal Funds," The Review of Economics and Statistics, MIT Press, vol. 95(1), pages 127-141, March.
    3. Alice Grady & Kirsty Seward & Meghan Finch & Luke Wolfenden & Rebecca Wyse & John Wiggers & Christophe Lecathelinais & Sze Lin Yoong, 2020. "A Three-Arm Randomised Controlled Trial of High- and Low-Intensity Implementation Strategies to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines: 12-Month Follow-Up," IJERPH, MDPI, vol. 17(13), pages 1-20, June.
    4. V. T. Farewell, 2008. "Comment: Advancing public sector performance analysis by Professor C. J. Heinrich," Applied Stochastic Models in Business and Industry, John Wiley & Sons, vol. 24(5), pages 391-395, September.

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