Study Designs and statistical analyses for biomarker research

Masahiko Gosho, Kengo Nagashima, Yasunori Sato

Research output: Contribution to journalReview article

34 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)8966-8986
Number of pages21
JournalSensors (Switzerland)
Volume12
Issue number7
DOIs
Publication statusPublished - 2012 Jul 1
Externally publishedYes

Fingerprint

biomarkers
Biomarkers
Research
streamlining
design analysis
statistical tests
Statistical tests
statistical analysis
Drug Discovery
Statistical methods
drugs

Keywords

  • Biomarker adaptive design
  • Confounding
  • Multiplicity
  • Predictive factor
  • Statistical test

ASJC Scopus subject areas

  • Electrical and Electronic Engineering
  • Atomic and Molecular Physics, and Optics
  • Analytical Chemistry
  • Biochemistry

Cite this

Study Designs and statistical analyses for biomarker research. / Gosho, Masahiko; Nagashima, Kengo; Sato, Yasunori.

In: Sensors (Switzerland), Vol. 12, No. 7, 01.07.2012, p. 8966-8986.

Research output: Contribution to journalReview article

Gosho, Masahiko ; Nagashima, Kengo ; Sato, Yasunori. / Study Designs and statistical analyses for biomarker research. In: Sensors (Switzerland). 2012 ; Vol. 12, No. 7. pp. 8966-8986.
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