Truncated robust distance for clinical laboratory safety data monitoring and assessment

J Biopharm Stat. 2012;22(6):1174-92. doi: 10.1080/10543406.2011.580483.

Abstract

Laboratory safety data are routinely collected in clinical studies for safety monitoring and assessment. We have developed a truncated robust multivariate outlier detection method for identifying subjects with clinically relevant abnormal laboratory measurements. The proposed method can be applied to historical clinical data to establish a multivariate decision boundary that can then be used for future clinical trial laboratory safety data monitoring and assessment. Simulations demonstrate that the proposed method has the ability to detect relevant outliers while automatically excluding irrelevant outliers. Two examples from actual clinical studies are used to illustrate the use of this method for identifying clinically relevant outliers.

MeSH terms

  • Biomarkers / blood
  • Clinical Trials as Topic / statistics & numerical data*
  • Computer Simulation
  • Data Interpretation, Statistical*
  • Drug Monitoring / statistics & numerical data*
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Lipoproteins, LDL / blood
  • Liver Function Tests
  • Models, Biological*
  • Models, Statistical*
  • Multivariate Analysis*
  • Safety / statistics & numerical data
  • Triglycerides / blood

Substances

  • Biomarkers
  • Lipoproteins, LDL
  • Triglycerides