Power and sample size determination in clinical trials with multiple primary continuous correlated endpoints

Pierre Lafaye de Micheaux, Benoit Liquet, Sébastien Marque, Jérémie Riou

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)

Abstract

The use of two or more primary correlated endpoints is becoming increasingly common. A mandatory approach when analyzing data from such clinical trials is to control the family-wise error rate (FWER). In this context, we provide formulas for computation of sample size and for data analysis. Two approaches are discussed: an individual method based on a union-intersection procedure and a global procedure, based on a multivariate model that can take into account adjustment variables. These methods are illustrated with simulation studies and applications. An R package known as rPowerSampleSize is also available.

Original languageEnglish
Pages (from-to)378-397
Number of pages20
JournalJournal of Biopharmaceutical Statistics
Volume24
Issue number2
DOIs
Publication statusPublished - 2014
Externally publishedYes

Keywords

  • Correlated endpoints
  • Family-Wise error rate
  • Multiple continuous endpoints
  • Multivariate normal distribution
  • Power
  • Sample size determination

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