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Related Experiment Videos

Power and sample size when multiple endpoints are considered.

Stephen Senn1, Frank Bretz

  • 1Department of Statistics, University of Glasgow, Glasgow, Scotland, UK.

Pharmaceutical Statistics
|August 4, 2007
PubMed
Summary
This summary is machine-generated.

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Controlling the family-wise error rate in clinical trials with multiple outcomes can reduce statistical power. However, this study shows that increasing the number of outcomes tested may not decrease overall trial power, even with Bonferroni corrections.

Area of Science:

  • Biostatistics
  • Clinical Trial Design

Background:

  • Analyzing clinical trials with multiple outcomes often involves controlling the family-wise error rate (FWER) to prevent false positives.
  • Common methods like Bonferroni corrections or closed-test procedures reduce individual test significance levels, potentially leading to a loss of statistical power.

Purpose of the Study:

  • To investigate whether increasing the number of outcomes tested in clinical trials necessarily leads to a decrease in overall statistical power.
  • To explore strategies for maintaining or even increasing trial power while controlling the FWER.

Main Methods:

  • Examined unstructured testing problems (multiple outcomes) using a Bonferroni approach with a latent variable model, assuming compound symmetry for variable correlations.
  • Analyzed structured testing problems (multiple treatments) through a numerical study.

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Main Results:

  • For unstructured problems, power is not reduced as the number of tested variables increases, provided the common correlation is below 0.75.
  • For structured problems, the numerical study also indicated that power does not decrease with an increasing number of tested variables.

Conclusions:

  • It is possible to increase the overall power of a clinical trial by testing multiple outcomes without increasing the probability of Type I errors.
  • Strategies exist to optimize power in multiple outcome and multiple treatment scenarios, challenging the assumption of inevitable power loss.