Journal
SENSORS
Volume 12, Issue 7, Pages 8966-8986Publisher
MDPI
DOI: 10.3390/s120708966
Keywords
biomarker adaptive design; confounding; multiplicity; predictive factor; statistical test
Funding
- Japan Society for the Promotion of Science
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Biomarkers are becoming increasingly important for streamlining drug discovery and development. In addition, biomarkers are widely expected to be used as a tool for disease diagnosis, personalized medication, and surrogate endpoints in clinical research. In this paper, we highlight several important aspects related to study design and statistical analysis for clinical research incorporating biomarkers. We describe the typical and current study designs for exploring, detecting, and utilizing biomarkers. Furthermore, we introduce statistical issues such as confounding and multiplicity for statistical tests in biomarker research.
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