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Practical guidelines for multiplicity adjustment in clinical trials.

M A Proschan1, M A Waclawiw

  • 1Office of Biostatistics Research, National Heart, Lung and Blood Institute, Bethesda, MD 20892-7938, USA. ProschaM@nih.gov

Controlled Clinical Trials
|January 9, 2001
PubMed
Summary

Clinical trials face multiplicity issues like multiple endpoints and comparisons, inflating error rates. This paper offers practical guidelines and key questions for deciding on necessary multiplicity adjustments.

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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Statistical Methods

Background:

  • Multiplicity in clinical trials arises from various sources, including multiple endpoints, treatment arms, and interim analyses.
  • It is widely acknowledged that multiplicity inflates the Type I error rate, necessitating statistical adjustments.

Purpose of the Study:

  • To provide practical guidelines for addressing the complex issue of multiplicity in clinical trials.
  • To clarify the fundamental issues and key considerations for deciding on the necessity and extent of multiplicity adjustments.

Main Methods:

  • The paper uses scenarios and examples to illustrate the concept of multiplicity.
  • It poses key questions to guide trialists in their decision-making process regarding multiplicity adjustments.

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Main Results:

  • The study highlights the controversial nature of multiplicity adjustment in clinical trials.
  • It emphasizes the need for careful deliberation on when and how to adjust for multiple comparisons.

Conclusions:

  • Navigating multiplicity in clinical trials requires a clear understanding of its impact on error rates.
  • Practical guidelines and critical questioning are essential for appropriate multiplicity adjustment strategies.